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Trial Outcomes & Findings for Health Systems Reach Interventions Project (NCT NCT04199117)

NCT ID: NCT04199117

Last Updated: 2025-09-24

Results Overview

The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over 1-year of study enrollment period, vs. 0=no evidence of treatment initiation).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

210 participants

Primary outcome timeframe

1 year

Results posted on

2025-09-24

Participant Flow

A total of 229 participants provided informed consent. A total of 210 consented participants completed the baseline assessments and randomization procedures and were considered fully enrolled in the trial.

Participant milestones

Participant milestones
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Overall Study
STARTED
9
16
12
14
10
11
10
18
11
16
11
17
12
15
11
17
Overall Study
COMPLETED
5
15
12
13
9
11
10
16
11
16
10
15
9
13
10
16
Overall Study
NOT COMPLETED
4
1
0
1
1
0
0
2
0
0
1
2
3
2
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Overall Study
Withdrawal by Subject
3
0
0
1
1
0
0
2
0
0
1
1
2
1
1
1
Overall Study
Death
1
1
0
0
0
0
0
0
0
0
0
1
0
1
0
0
Overall Study
Withdrawal by PI
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0

Baseline Characteristics

Health Systems Reach Interventions Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
n=9 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
n=14 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
n=11 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
n=18 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
n=15 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Total
n=210 Participants
Total of all reporting groups
Age, Continuous
54.11 years
STANDARD_DEVIATION 13.20 • n=5 Participants
53.81 years
STANDARD_DEVIATION 12.14 • n=7 Participants
47.33 years
STANDARD_DEVIATION 13.42 • n=5 Participants
48.57 years
STANDARD_DEVIATION 13.92 • n=4 Participants
59.30 years
STANDARD_DEVIATION 14.16 • n=21 Participants
47.46 years
STANDARD_DEVIATION 14.08 • n=8 Participants
49.60 years
STANDARD_DEVIATION 12.80 • n=8 Participants
49.67 years
STANDARD_DEVIATION 13.39 • n=24 Participants
53.27 years
STANDARD_DEVIATION 11.23 • n=42 Participants
48.88 years
STANDARD_DEVIATION 14.25 • n=42 Participants
54.82 years
STANDARD_DEVIATION 12.15 • n=42 Participants
48.18 years
STANDARD_DEVIATION 14.63 • n=42 Participants
49.75 years
STANDARD_DEVIATION 14.25 • n=36 Participants
47.73 years
STANDARD_DEVIATION 13.68 • n=36 Participants
54.73 years
STANDARD_DEVIATION 12.41 • n=24 Participants
52.12 years
STANDARD_DEVIATION 17.39 • n=135 Participants
50.91 years
STANDARD_DEVIATION 13.65 • n=136 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
11 Participants
n=7 Participants
8 Participants
n=5 Participants
11 Participants
n=4 Participants
8 Participants
n=21 Participants
8 Participants
n=8 Participants
7 Participants
n=8 Participants
11 Participants
n=24 Participants
7 Participants
n=42 Participants
10 Participants
n=42 Participants
9 Participants
n=42 Participants
12 Participants
n=42 Participants
9 Participants
n=36 Participants
9 Participants
n=36 Participants
11 Participants
n=24 Participants
9 Participants
n=135 Participants
147 Participants
n=136 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
5 Participants
n=7 Participants
4 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
3 Participants
n=8 Participants
3 Participants
n=8 Participants
7 Participants
n=24 Participants
4 Participants
n=42 Participants
6 Participants
n=42 Participants
2 Participants
n=42 Participants
5 Participants
n=42 Participants
3 Participants
n=36 Participants
6 Participants
n=36 Participants
0 Participants
n=24 Participants
8 Participants
n=135 Participants
63 Participants
n=136 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
9 Participants
n=21 Participants
1 Participants
n=8 Participants
2 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
2 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
2 Participants
n=24 Participants
3 Participants
n=135 Participants
23 Participants
n=136 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
16 Participants
n=7 Participants
11 Participants
n=5 Participants
12 Participants
n=4 Participants
1 Participants
n=21 Participants
10 Participants
n=8 Participants
8 Participants
n=8 Participants
18 Participants
n=24 Participants
10 Participants
n=42 Participants
14 Participants
n=42 Participants
10 Participants
n=42 Participants
16 Participants
n=42 Participants
12 Participants
n=36 Participants
15 Participants
n=36 Participants
9 Participants
n=24 Participants
14 Participants
n=135 Participants
185 Participants
n=136 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
2 Participants
n=136 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
2 Participants
n=136 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
1 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
2 Participants
n=136 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
7 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
3 Participants
n=21 Participants
3 Participants
n=8 Participants
3 Participants
n=8 Participants
10 Participants
n=24 Participants
6 Participants
n=42 Participants
8 Participants
n=42 Participants
2 Participants
n=42 Participants
3 Participants
n=42 Participants
3 Participants
n=36 Participants
6 Participants
n=36 Participants
4 Participants
n=24 Participants
4 Participants
n=135 Participants
72 Participants
n=136 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
8 Participants
n=7 Participants
8 Participants
n=5 Participants
8 Participants
n=4 Participants
7 Participants
n=21 Participants
5 Participants
n=8 Participants
5 Participants
n=8 Participants
8 Participants
n=24 Participants
4 Participants
n=42 Participants
6 Participants
n=42 Participants
7 Participants
n=42 Participants
8 Participants
n=42 Participants
8 Participants
n=36 Participants
9 Participants
n=36 Participants
6 Participants
n=24 Participants
8 Participants
n=135 Participants
110 Participants
n=136 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
2 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
2 Participants
n=42 Participants
3 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
1 Participants
n=24 Participants
2 Participants
n=135 Participants
16 Participants
n=136 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
3 Participants
n=135 Participants
8 Participants
n=136 Participants
Region of Enrollment
United States
9 participants
n=5 Participants
16 participants
n=7 Participants
12 participants
n=5 Participants
14 participants
n=4 Participants
10 participants
n=21 Participants
11 participants
n=8 Participants
10 participants
n=8 Participants
18 participants
n=24 Participants
11 participants
n=42 Participants
16 participants
n=42 Participants
11 participants
n=42 Participants
17 participants
n=42 Participants
12 participants
n=36 Participants
15 participants
n=36 Participants
11 participants
n=24 Participants
17 participants
n=135 Participants
210 participants
n=136 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All randomized participants

The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over 1-year of study enrollment period, vs. 0=no evidence of treatment initiation).

Outcome measures

Outcome measures
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
n=9 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
n=14 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
n=11 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
n=18 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
n=15 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Number of Participants Who Initiate Treatment Over 1 Year of Study Enrollment
0 Participants
2 Participants
1 Participants
0 Participants
4 Participants
1 Participants
1 Participants
0 Participants
3 Participants
0 Participants
2 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All randomized participants

The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over the 2-year study enrollment period, vs. 0=no evidence of treatment initiation).

Outcome measures

Outcome measures
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
n=9 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
n=14 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
n=11 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
n=18 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
n=15 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Number of Participants Who Initiate Treatment Over 2 Years of Study Enrollment
1 Participants
2 Participants
2 Participants
1 Participants
5 Participants
3 Participants
5 Participants
0 Participants
4 Participants
0 Participants
3 Participants
0 Participants
2 Participants
0 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: 2 years from enrollment

Population: All randomized participants

All study participants randomized to experimental condition will be asked to report on any smoking in the last 7 days at a follow-up phone interview 2 years after enrollment. Those claiming complete abstinence in the past 7 days at this follow-up interview will be asked to provide a saliva sample for biochemical verification of abstinence via cotinine testing. Participants who report abstinence in the last 7 days at this visit but have a cotinine level \>10ng/mL or who do not have provide a cotinine result will be considered to be smoking. Missing data will be coded as not abstinent in primary, intent-to-treat analyses.

Outcome measures

Outcome measures
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
n=9 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
n=14 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
n=11 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
n=10 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
n=18 Participants
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
n=16 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
n=12 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
n=15 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
n=11 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
n=17 Participants
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Number of Participants Who Achieve Biochemically Verified Seven-day Point Prevalence Abstinence 2 Years Post-enrollment
0 Participants
2 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
2 Participants
0 Participants
1 Participants
1 Participants
0 Participants
1 Participants
0 Participants
2 Participants
2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

The costs of implementing each intervention in the first year (minus research-related costs) will be computed from healthcare utilization, service, medication, administrative, and patient-report data. This outcome will be used to determine first-year costs of implementing each intervention component and highly promising intervention packages.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

The costs of maintaining implementation of each intervention (minus research-related costs) will be computed from healthcare utilization, service, medication, administrative, and patient-report data. This outcome will be used to determine the costs of maintaining implementation of each intervention component and highly promising intervention packages.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

This outcome will be coded with a binary indicator of whether or not participants randomly assigned to have access to intensive treatment with C-NRT or varenicline completed a full round of treatment at any point over 2 years. Completion is defined as completing three phone counseling sessions.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 12, and 26 weeks post-target quit day

Self-reported 7-day point prevalence abstinence will be determined from participants who attempt to quit at 3 telephone follow-ups during an assisted quit attempt. At all 3 time-points, 7-day point-prevalence abstinence will be coded as binary (1=abstinent, not even a puff, in the past 7 days, per self-report, or 0=any smoking in the past 7 days), with missing treated as smoking in primary, intent-to-treat analyses.

Outcome measures

Outcome data not reported

Adverse Events

Incentive,Tailored,Care Manage,Intensive Treatment

Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths

Incentive,Tailored,Care Manage,Standard Treatment

Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths

Incentive,Tailored,No Care Manage,Intensive Treatment

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Incentive,Tailored,No Care Manage,Standard Treatment

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Incentive,Untailored,Care Manage,Intensive Treatment

Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths

Incentive,Untailored,Care Manage,Standard Treatment

Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths

Incentive,Untailored,No Care Manage,Intensive Treatment

Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths

Incentive,Untailored,No Care Manage,Standard Treatment

Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths

No Incentive,Tailored,Care Manage,Intensive Treatment

Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths

No Incentive,Tailored,Care Manage,Standard Treatment

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

No Incentive,Tailored,No Care Manage,Intensive Treatment

Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths

No Incentive,Tailored,No Care Manage,Standard Treatment

Serious events: 5 serious events
Other events: 0 other events
Deaths: 2 deaths

No Incentive,Untailored,Care Manage,Intensive Treatment

Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths

No Incentive,Untailored,Care Manage,Standard Treatment

Serious events: 9 serious events
Other events: 1 other events
Deaths: 1 deaths

No Incentive,Untailored,No Care Manage,IntensiveTreatment

Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths

No Incentive,Untailored,No Care Manage,Standard Treatment

Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
n=9 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
n=16 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
n=12 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
n=14 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
n=10 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
n=11 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
n=10 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
n=18 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
n=11 participants at risk
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
n=16 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
n=11 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
n=17 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
n=12 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
n=15 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
n=11 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
n=17 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Cardiac disorders
Cardiac event or disease requiring hospitalization
22.2%
2/9 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
12.5%
2/16 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
17.6%
3/17 • Number of events 3 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.7%
1/15 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Nervous system disorders
Nervous system disorder requiring hospitalization or emergency care
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.6%
1/18 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
13.3%
2/15 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Surgical and medical procedures
Surgery with hospitalization
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.6%
1/18 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
18.2%
2/11 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
13.3%
2/15 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
18.2%
2/11 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Respiratory, thoracic and mediastinal disorders
Respiratory illness requiring hospitalization
11.1%
1/9 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.6%
1/18 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
17.6%
3/17 • Number of events 3 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
26.7%
4/15 • Number of events 4 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Gastrointestinal disorders
Constipation, bowel obstruction, diarrhea requiring hospitalization
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
16.7%
2/12 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.7%
1/15 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Psychiatric disorders
Psychiatric hospitalization
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.6%
1/18 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Pregnancy, puerperium and perinatal conditions
Pregnancy-related problems requiring hospitalization
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
11.1%
2/18 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Renal and urinary disorders
Renal or urinary issues
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Hepatobiliary disorders
Hospitalization for gallstones
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New cancer diagnoses
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
7.1%
1/14 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.7%
1/15 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Musculoskeletal and connective tissue disorders
Muscoskeletal injury prompting emergency care or hospitalization
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
18.2%
2/11 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Endocrine disorders
Endocrine-related hospitalization
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
General disorders
Unknown or other cause of death or hospitalization
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
12.5%
2/16 • Number of events 2 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
20.0%
3/15 • Number of events 3 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.

Other adverse events

Other adverse events
Measure
Incentive,Tailored,Care Manage,Intensive Treatment
n=9 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,Care Manage,Standard Treatment
n=16 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Tailored,No Care Manage,Intensive Treatment
n=12 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Tailored,No Care Manage,Standard Treatment
n=14 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,Care Manage,Intensive Treatment
n=10 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,Care Manage,Standard Treatment
n=11 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Incentive,Untailored,No Care Manage,Intensive Treatment
n=10 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Incentive,Untailored,No Care Manage,Standard Treatment
n=18 participants at risk
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,Care Manage,Intensive Treatment
n=11 participants at risk
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,Care Manage,Standard Treatment
n=16 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Tailored,No Care Manage,Intensive Treatment
n=11 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Tailored,No Care Manage,Standard Treatment
n=17 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,Care Manage,Intensive Treatment
n=12 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,Care Manage,Standard Treatment
n=15 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
No Incentive,Untailored,No Care Manage,IntensiveTreatment
n=11 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
No Incentive,Untailored,No Care Manage,Standard Treatment
n=17 participants at risk
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Gastrointestinal disorders
Nausea or vomiting
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
General disorders
Dizziness or weakness
11.1%
1/9 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Gastrointestinal disorders
Gas, constipation, or indigestion
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
8.3%
1/12 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.7%
1/15 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
General disorders
Insomnia or vivid dreams
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
9.1%
1/11 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Respiratory, thoracic and mediastinal disorders
Chest tightness or difficulty breathing
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
7.1%
1/14 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Psychiatric disorders
Changes in mood
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
10.0%
1/10 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/15 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
Gastrointestinal disorders
Hiccups
0.00%
0/9 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/14 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/10 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/18 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/16 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/12 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
6.7%
1/15 • Number of events 1 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/11 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.
0.00%
0/17 • 2 years
Adverse events were assessed systematically at follow-up phone interviews 6, 12, 18, and 24 months after enrollment and 3, 12, and 26 weeks after any target quit dates set by participants who initiated treatment in the study.

Additional Information

Danielle McCarthy, Ph.D.

University of Wisconsin School of Medicine and Public Health

Phone: 6082655949

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place