Trial Outcomes & Findings for Evaluation of Treatments to Improve Smoking Cessation Medication Adherence (NCT NCT01120704)
NCT ID: NCT01120704
Last Updated: 2015-12-11
Results Overview
Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
544 participants
Primary outcome timeframe
Assessed at 52 weeks after target quit day
Results posted on
2015-12-11
Participant Flow
Participant milestones
| Measure |
1, 26Wks, Counseling, CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
2, 26Wks, Counseling, CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
3, 26Wks, Counseling, CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
5, 26Wks, Counseling, No CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
9, 26Wks, No Counseling, CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
17, 8Wks, Counseling, CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
18, 8Wks, Counseling, CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
19, 8Wks, Counseling, CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
21, 8Wks, Counseling, No CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
25, 8Wks, No Counseling, CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
17
|
14
|
19
|
16
|
19
|
15
|
15
|
22
|
20
|
17
|
16
|
17
|
19
|
18
|
18
|
14
|
16
|
17
|
18
|
17
|
16
|
21
|
16
|
18
|
14
|
18
|
18
|
19
|
15
|
14
|
18
|
|
Overall Study
COMPLETED
|
10
|
13
|
13
|
15
|
14
|
18
|
12
|
13
|
19
|
19
|
16
|
14
|
14
|
15
|
17
|
16
|
13
|
16
|
15
|
15
|
14
|
16
|
17
|
13
|
16
|
14
|
15
|
16
|
14
|
12
|
12
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
4
|
2
|
1
|
3
|
2
|
3
|
1
|
1
|
2
|
3
|
4
|
1
|
2
|
1
|
0
|
2
|
3
|
3
|
0
|
4
|
3
|
2
|
0
|
3
|
2
|
5
|
3
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Baseline characteristics by cohort
| Measure |
1, 26Wks, Counseling, CAM, AutoCalls, Feedback
n=13 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
2, 26Wks, Counseling, CAM, AutoCalls, No Feedback
n=17 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
3, 26Wks, Counseling, CAM, No AutoCalls, Feedback
n=14 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback
n=19 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
5, 26Wks, Counseling, No CAM, AutoCalls, Feedback
n=16 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback
n=19 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback
n=15 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback
n=15 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
9, 26Wks, No Counseling, CAM, AutoCalls, Feedback
n=22 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback
n=20 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback
n=17 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback
n=16 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback
n=17 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback
n=19 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback
n=18 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback
n=18 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
17, 8Wks, Counseling, CAM, AutoCalls, Feedback
n=14 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
18, 8Wks, Counseling, CAM, AutoCalls, No Feedback
n=16 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
19, 8Wks, Counseling, CAM, No AutoCalls, Feedback
n=17 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback
n=18 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
21, 8Wks, Counseling, No CAM, AutoCalls, Feedback
n=17 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback
n=16 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback
n=21 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback
n=16 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
25, 8Wks, No Counseling, CAM, AutoCalls, Feedback
n=18 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback
n=14 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback
n=18 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback
n=18 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback
n=19 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback
n=15 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback
n=14 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
|
32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback
n=18 Participants
This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
|
Total
n=544 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
0 Participants
n=115 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
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
17 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
15 Participants
n=135 Participants
|
10 Participants
n=136 Participants
|
15 Participants
n=44 Participants
|
16 Participants
n=667 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=6 Participants
|
12 Participants
n=10 Participants
|
16 Participants
n=14 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=4 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=26 Participants
|
17 Participants
n=12 Participants
|
19 Participants
n=206 Participants
|
14 Participants
n=32 Participants
|
12 Participants
n=117 Participants
|
16 Participants
n=100 Participants
|
493 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=117 Participants
|
2 Participants
n=100 Participants
|
49 Participants
n=20 Participants
|
|
Age, Continuous
|
45.08 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
43.82 years
STANDARD_DEVIATION 9.87 • n=7 Participants
|
39.86 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
49.42 years
STANDARD_DEVIATION 14.25 • n=4 Participants
|
48.81 years
STANDARD_DEVIATION 14.61 • n=21 Participants
|
48.89 years
STANDARD_DEVIATION 9.72 • n=10 Participants
|
47.33 years
STANDARD_DEVIATION 9.83 • n=115 Participants
|
43.53 years
STANDARD_DEVIATION 8.32 • n=24 Participants
|
51.55 years
STANDARD_DEVIATION 13.51 • n=42 Participants
|
46.50 years
STANDARD_DEVIATION 11.04 • n=42 Participants
|
44.29 years
STANDARD_DEVIATION 10.71 • n=42 Participants
|
46.69 years
STANDARD_DEVIATION 11.44 • n=42 Participants
|
46.41 years
STANDARD_DEVIATION 9.56 • n=36 Participants
|
44.58 years
STANDARD_DEVIATION 13.68 • n=36 Participants
|
49.33 years
STANDARD_DEVIATION 17.49 • n=24 Participants
|
50.39 years
STANDARD_DEVIATION 12.56 • n=135 Participants
|
49.07 years
STANDARD_DEVIATION 16.28 • n=136 Participants
|
47.00 years
STANDARD_DEVIATION 13.11 • n=44 Participants
|
42.53 years
STANDARD_DEVIATION 12.86 • n=667 Participants
|
45.72 years
STANDARD_DEVIATION 12.91 • n=7 Participants
|
47.35 years
STANDARD_DEVIATION 12.80 • n=6 Participants
|
51.81 years
STANDARD_DEVIATION 13.97 • n=10 Participants
|
48.76 years
STANDARD_DEVIATION 14.45 • n=14 Participants
|
39.19 years
STANDARD_DEVIATION 11.64 • n=4 Participants
|
45.50 years
STANDARD_DEVIATION 12.71 • n=4 Participants
|
41.50 years
STANDARD_DEVIATION 10.71 • n=4 Participants
|
42.67 years
STANDARD_DEVIATION 14.20 • n=26 Participants
|
45.72 years
STANDARD_DEVIATION 10.60 • n=12 Participants
|
39.53 years
STANDARD_DEVIATION 12.25 • n=206 Participants
|
45.33 years
STANDARD_DEVIATION 12.69 • n=32 Participants
|
47.21 years
STANDARD_DEVIATION 16.61 • n=117 Participants
|
46.78 years
STANDARD_DEVIATION 13.12 • n=100 Participants
|
46.12 years
STANDARD_DEVIATION 12.76 • n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
9 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
12 Participants
n=14 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=26 Participants
|
10 Participants
n=12 Participants
|
12 Participants
n=206 Participants
|
9 Participants
n=32 Participants
|
8 Participants
n=117 Participants
|
11 Participants
n=100 Participants
|
321 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=10 Participants
|
9 Participants
n=14 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=26 Participants
|
8 Participants
n=12 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=32 Participants
|
6 Participants
n=117 Participants
|
7 Participants
n=100 Participants
|
223 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
14 participants
n=5 Participants
|
19 participants
n=4 Participants
|
16 participants
n=21 Participants
|
19 participants
n=10 Participants
|
15 participants
n=115 Participants
|
15 participants
n=24 Participants
|
22 participants
n=42 Participants
|
20 participants
n=42 Participants
|
17 participants
n=42 Participants
|
16 participants
n=42 Participants
|
17 participants
n=36 Participants
|
19 participants
n=36 Participants
|
18 participants
n=24 Participants
|
18 participants
n=135 Participants
|
14 participants
n=136 Participants
|
16 participants
n=44 Participants
|
17 participants
n=667 Participants
|
18 participants
n=7 Participants
|
17 participants
n=6 Participants
|
16 participants
n=10 Participants
|
21 participants
n=14 Participants
|
16 participants
n=4 Participants
|
18 participants
n=4 Participants
|
14 participants
n=4 Participants
|
18 participants
n=26 Participants
|
18 participants
n=12 Participants
|
19 participants
n=206 Participants
|
15 participants
n=32 Participants
|
14 participants
n=117 Participants
|
18 participants
n=100 Participants
|
544 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Assessed at 52 weeks after target quit daySelf-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence.
Outcome measures
| Measure |
8 Weeks of Nicotine Patch and Nicotine Gum
n=269 Participants
Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
|
26 Weeks of Nicotine Patch and Nicotine Gum
n=275 Participants
Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
|
No Maintenance Counseling
n=281 Participants
Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
|
Maintenance Counseling
n=263 Participants
Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
|
No Cognitive Medication Adherence Counseling
n=273 Participants
Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
|
Cognitive Medication Adherence Counseling
n=271 Participants
Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
|
Electronic Medication Monitoring Device Without Feedback
n=272 Participants
Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
|
Electronic Medication Monitoring Device Plus Feedback
n=272 Participants
Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
|
No Automated Adherence Prompting Phone Calls
n=274 Participants
Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
|
Automated Adherence Prompting Phone Calls
n=270 Participants
Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Self-Reported 7-Day Point-Prevalence Abstinence
# Participants Who Smoking
|
197 participants
|
181 participants
|
202 participants
|
176 participants
|
184 participants
|
194 participants
|
186 participants
|
192 participants
|
198 participants
|
180 participants
|
|
Self-Reported 7-Day Point-Prevalence Abstinence
# Participants Who Are Abstinent
|
72 participants
|
94 participants
|
79 participants
|
87 participants
|
89 participants
|
77 participants
|
86 participants
|
80 participants
|
76 participants
|
90 participants
|
SECONDARY outcome
Timeframe: Assessed during the first 12 months post-quit after target quit dayLatency to Relapse during the first 12 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored
Outcome measures
| Measure |
8 Weeks of Nicotine Patch and Nicotine Gum
n=269 Participants
Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
|
26 Weeks of Nicotine Patch and Nicotine Gum
n=275 Participants
Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
|
No Maintenance Counseling
n=281 Participants
Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
|
Maintenance Counseling
n=263 Participants
Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
|
No Cognitive Medication Adherence Counseling
n=273 Participants
Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
|
Cognitive Medication Adherence Counseling
n=271 Participants
Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
|
Electronic Medication Monitoring Device Without Feedback
n=274 Participants
Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
|
Electronic Medication Monitoring Device Plus Feedback
n=270 Participants
Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
|
No Automated Adherence Prompting Phone Calls
n=272 Participants
Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
|
Automated Adherence Prompting Phone Calls
n=272 Participants
Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Latency to Relapse
# Participants Who Relapsed (Smoking)
|
227 participants
|
209 participants
|
228 participants
|
208 participants
|
214 participants
|
222 participants
|
225 participants
|
211 participants
|
218 participants
|
218 participants
|
|
Latency to Relapse
# Participants Who Did Not Relapse (Not Smoking)
|
42 participants
|
66 participants
|
53 participants
|
55 participants
|
59 participants
|
49 participants
|
49 participants
|
59 participants
|
54 participants
|
54 participants
|
Adverse Events
26 Weeks of Nicotine Patch and Nicotine Gum
Serious events: 10 serious events
Other events: 146 other events
Deaths: 0 deaths
8 Weeks of Nicotine Patch and Nicotine Gum
Serious events: 6 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
26 Weeks of Nicotine Patch and Nicotine Gum
n=275 participants at risk
Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum.
IF the participant smoked \>10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication
|
8 Weeks of Nicotine Patch and Nicotine Gum
n=269 participants at risk
Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum.
IF participant smoked \>10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
1.5%
4/275 • Number of events 4 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
1.9%
5/269 • Number of events 6 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.36%
1/275 • Number of events 1 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.00%
0/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.73%
2/275 • Number of events 2 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.00%
0/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.36%
1/275 • Number of events 1 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.00%
0/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.36%
1/275 • Number of events 1 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.00%
0/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
General disorders
Death-unknown cause
|
0.36%
1/275 • Number of events 1 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.37%
1/269 • Number of events 1 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
Other adverse events
| Measure |
26 Weeks of Nicotine Patch and Nicotine Gum
n=275 participants at risk
Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum.
IF the participant smoked \>10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication
|
8 Weeks of Nicotine Patch and Nicotine Gum
n=269 participants at risk
Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum.
IF participant smoked \>10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
8.4%
23/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
7.1%
19/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Nervous system disorders
Headache
|
8.7%
24/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
7.1%
19/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Gastrointestinal disorders
Indigestion
|
10.2%
28/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
10.4%
28/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Nervous system disorders
Insomnia
|
10.5%
29/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
11.5%
31/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Skin and subcutaneous tissue disorders
Itches or Hives
|
10.2%
28/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
6.7%
18/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Gastrointestinal disorders
Mouth Problems
|
6.2%
17/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
6.7%
18/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Gastrointestinal disorders
Nausea
|
14.5%
40/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
14.5%
39/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
22.9%
63/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
18.6%
50/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Nervous system disorders
VividDreams
|
16.0%
44/275 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
19.3%
52/269 • AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.)
Protocol prompted AE assessments occurred at weeks 1, 4, 8 (and 16 for those on medication for 16 weeks) postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place