Trial Outcomes & Findings for Identifying Optimal Smoking Cessation Intervention Components (Cessation) (NCT NCT01116986)
NCT ID: NCT01116986
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 (16 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 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
637 participants
Primary outcome timeframe
16 weeks post-quit
Results posted on
2015-12-11
Participant Flow
Participant milestones
| Measure |
1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt.
|
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
19
|
18
|
22
|
24
|
22
|
22
|
22
|
20
|
23
|
19
|
20
|
17
|
19
|
17
|
21
|
16
|
24
|
23
|
15
|
24
|
20
|
23
|
21
|
18
|
19
|
18
|
19
|
17
|
17
|
17
|
17
|
|
Overall Study
COMPLETED
|
22
|
16
|
16
|
20
|
20
|
20
|
20
|
20
|
19
|
19
|
18
|
20
|
16
|
16
|
17
|
15
|
13
|
19
|
20
|
13
|
22
|
18
|
19
|
19
|
15
|
19
|
14
|
18
|
17
|
17
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
2
|
4
|
2
|
2
|
2
|
1
|
4
|
1
|
0
|
1
|
3
|
0
|
6
|
3
|
5
|
3
|
2
|
2
|
2
|
4
|
2
|
3
|
0
|
4
|
1
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identifying Optimal Smoking Cessation Intervention Components (Cessation)
Baseline characteristics by cohort
| Measure |
1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk
n=24 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk
n=19 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk
n=18 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk
n=22 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk
n=24 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk
n=22 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk
n=22 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk
n=22 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
n=20 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk
n=23 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk
n=19 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk
n=20 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk
n=17 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk
n=19 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk
n=17 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk
n=21 Participants
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk
n=16 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk
n=24 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk
n=23 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt.
|
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk
n=15 Participants
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk
n=24 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk
n=20 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk
n=23 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk
n=21 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk
n=18 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk
n=19 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk
n=18 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk
n=19 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16
n=17 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W
n=17 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W
n=17 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
|
32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16
n=17 Participants
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
|
Total
n=637 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
|
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
|
1 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
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=384 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
17 Participants
n=24 Participants
|
20 Participants
n=135 Participants
|
15 Participants
n=136 Participants
|
23 Participants
n=44 Participants
|
22 Participants
n=667 Participants
|
15 Participants
n=15 Participants
|
23 Participants
n=40 Participants
|
20 Participants
n=40 Participants
|
21 Participants
n=41 Participants
|
20 Participants
n=600 Participants
|
18 Participants
n=4 Participants
|
19 Participants
n=4 Participants
|
14 Participants
n=26 Participants
|
17 Participants
n=12 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=12 Participants
|
16 Participants
n=12 Participants
|
17 Participants
n=12 Participants
|
607 Participants
n=384 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 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
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=26 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
27 Participants
n=384 Participants
|
|
Age, Continuous
|
48.54 years
STANDARD_DEVIATION 9.90 • n=5 Participants
|
44.79 years
STANDARD_DEVIATION 11.67 • n=7 Participants
|
44.28 years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
43.91 years
STANDARD_DEVIATION 13.19 • n=4 Participants
|
50.0 years
STANDARD_DEVIATION 12.03 • n=21 Participants
|
41.50 years
STANDARD_DEVIATION 12.50 • n=8 Participants
|
46.86 years
STANDARD_DEVIATION 11.67 • n=8 Participants
|
39.73 years
STANDARD_DEVIATION 13.58 • n=24 Participants
|
43.00 years
STANDARD_DEVIATION 14.18 • n=42 Participants
|
47.43 years
STANDARD_DEVIATION 10.75 • n=42 Participants
|
46.26 years
STANDARD_DEVIATION 11.84 • n=42 Participants
|
45.10 years
STANDARD_DEVIATION 12.23 • n=42 Participants
|
42.53 years
STANDARD_DEVIATION 12.58 • n=36 Participants
|
42.63 years
STANDARD_DEVIATION 9.75 • n=36 Participants
|
44.94 years
STANDARD_DEVIATION 10.97 • n=24 Participants
|
50.05 years
STANDARD_DEVIATION 8.87 • n=135 Participants
|
47.13 years
STANDARD_DEVIATION 10.68 • n=136 Participants
|
45.83 years
STANDARD_DEVIATION 11.45 • n=44 Participants
|
43.83 years
STANDARD_DEVIATION 13.66 • n=667 Participants
|
45.20 years
STANDARD_DEVIATION 14.56 • n=15 Participants
|
47.38 years
STANDARD_DEVIATION 9.57 • n=40 Participants
|
46.30 years
STANDARD_DEVIATION 12.09 • n=40 Participants
|
44.17 years
STANDARD_DEVIATION 12.51 • n=41 Participants
|
45.33 years
STANDARD_DEVIATION 9.98 • n=600 Participants
|
45.00 years
STANDARD_DEVIATION 11.78 • n=4 Participants
|
46.32 years
STANDARD_DEVIATION 12.87 • n=4 Participants
|
54.56 years
STANDARD_DEVIATION 11.59 • n=26 Participants
|
48.37 years
STANDARD_DEVIATION 12.95 • n=12 Participants
|
41.82 years
STANDARD_DEVIATION 15.02 • n=206 Participants
|
48.29 years
STANDARD_DEVIATION 13.96 • n=12 Participants
|
51.18 years
STANDARD_DEVIATION 10.00 • n=12 Participants
|
40.65 years
STANDARD_DEVIATION 11.25 • n=12 Participants
|
45.73 years
STANDARD_DEVIATION 12.05 • n=384 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
11 Participants
n=667 Participants
|
9 Participants
n=15 Participants
|
13 Participants
n=40 Participants
|
11 Participants
n=40 Participants
|
13 Participants
n=41 Participants
|
11 Participants
n=600 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=26 Participants
|
10 Participants
n=12 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
348 Participants
n=384 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
6 Participants
n=15 Participants
|
11 Participants
n=40 Participants
|
9 Participants
n=40 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=600 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=26 Participants
|
9 Participants
n=12 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
289 Participants
n=384 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
18 participants
n=5 Participants
|
22 participants
n=4 Participants
|
24 participants
n=21 Participants
|
22 participants
n=8 Participants
|
22 participants
n=8 Participants
|
22 participants
n=24 Participants
|
20 participants
n=42 Participants
|
23 participants
n=42 Participants
|
19 participants
n=42 Participants
|
20 participants
n=42 Participants
|
17 participants
n=36 Participants
|
19 participants
n=36 Participants
|
17 participants
n=24 Participants
|
21 participants
n=135 Participants
|
16 participants
n=136 Participants
|
24 participants
n=44 Participants
|
23 participants
n=667 Participants
|
15 participants
n=15 Participants
|
24 participants
n=40 Participants
|
20 participants
n=40 Participants
|
23 participants
n=41 Participants
|
21 participants
n=600 Participants
|
18 participants
n=4 Participants
|
19 participants
n=4 Participants
|
18 participants
n=26 Participants
|
19 participants
n=12 Participants
|
17 participants
n=206 Participants
|
17 participants
n=12 Participants
|
17 participants
n=12 Participants
|
17 participants
n=12 Participants
|
637 participants
n=384 Participants
|
PRIMARY outcome
Timeframe: 16 weeks post-quitSelf-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 (16 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 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome.
Outcome measures
| Measure |
No Pre-Quit Nicotine Patch
n=308 Participants
Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
|
Pre-Quit Nicotine Patch
n=329 Participants
Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
|
No Pre-Quit Nicotine Gum
n=298 Participants
Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
|
Pre-Quit Nicotine Gum
n=339 Participants
Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
|
No Counseling Before the Quit Attempt
n=320 Participants
Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
|
Counseling Before the Quit Attempt
n=317 Participants
Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
|
Minimal In-person Counseling During the Quit Attempt
n=323 Participants
Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
|
Intensive In-person Counseling During the Quit Attempt
n=314 Participants
Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
|
Minimal Phone Counseling During the Quit Attemp
n=317 Participants
Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
|
Intensive Phone Counseling During the Quit Attempt
n=320 Participants
Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
|
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=333 Participants
Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
|
Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=304 Participants
Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Self-Reported 7-Day Point-Prevalence Abstinence
# Participants Who Were Abstinent
|
100 participants
|
120 participants
|
97 participants
|
123 participants
|
99 participants
|
121 participants
|
106 participants
|
114 participants
|
106 participants
|
114 participants
|
110 participants
|
110 participants
|
|
Self-Reported 7-Day Point-Prevalence Abstinence
# Participants Who Were Smoking
|
208 participants
|
209 participants
|
201 participants
|
216 participants
|
221 participants
|
196 participants
|
217 participants
|
200 participants
|
211 participants
|
206 participants
|
223 participants
|
194 participants
|
SECONDARY outcome
Timeframe: During the first 6 months post-quitLatency to Relapse during the first 6 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 |
No Pre-Quit Nicotine Patch
n=308 Participants
Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
|
Pre-Quit Nicotine Patch
n=329 Participants
Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
|
No Pre-Quit Nicotine Gum
n=298 Participants
Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
|
Pre-Quit Nicotine Gum
n=339 Participants
Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
|
No Counseling Before the Quit Attempt
n=320 Participants
Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
|
Counseling Before the Quit Attempt
n=317 Participants
Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
|
Minimal In-person Counseling During the Quit Attempt
n=323 Participants
Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
|
Intensive In-person Counseling During the Quit Attempt
n=314 Participants
Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
|
Minimal Phone Counseling During the Quit Attemp
n=317 Participants
Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
|
Intensive Phone Counseling During the Quit Attempt
n=320 Participants
Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
|
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=333 Participants
Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
|
Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=304 Participants
Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Latency to Relapse
# Participants Who Relapsed (Smoking)
|
235 participants
|
243 participants
|
228 participants
|
250 participants
|
243 participants
|
235 participants
|
246 participants
|
232 participants
|
242 participants
|
236 participants
|
246 participants
|
232 participants
|
|
Latency to Relapse
# Participants Who Did Not Relapse (Not Smoking)
|
73 participants
|
86 participants
|
70 participants
|
89 participants
|
77 participants
|
82 participants
|
77 participants
|
82 participants
|
75 participants
|
84 participants
|
87 participants
|
72 participants
|
Adverse Events
Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Pre-Quit Nicotine Patch
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Pre-Quit Nicotine Gum
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
No Pre-Quit Nicotine Patch Nor Gum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch
n=173 participants at risk
Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch
Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch.
Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
|
Pre-Quit Nicotine Patch
n=156 participants at risk
Pre-Quit Nicotine Patch
Participants randomized to this condition received Pre-Quit Nicotine Patch.
Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day.
|
Pre-Quit Nicotine Gum
n=166 participants at risk
Pre-Quit Nicotine Gum
Participants randomized to this condition received Pre-Quit Nicotine Gum.
Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day.
|
No Pre-Quit Nicotine Patch Nor Gum
n=142 participants at risk
No Pre-Quit Nicotine Patch nor Gum
Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum.
|
Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=304 participants at risk；n=333 participants at risk
Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum
Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt.
|
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=333 participants at risk；n=304 participants at risk
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Death- Gastrointestinal
|
0.00%
0/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.30%
1/333 • Number of events 1 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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
Neurological
|
0.00%
0/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.30%
1/333 • Number of events 1 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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
|
0.00%
0/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.30%
1/333 • Number of events 1 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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
|
0.00%
0/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.30%
1/333 • Number of events 1 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
|
Renal and urinary disorders
Renal
|
0.00%
0/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.64%
1/156 • Number of events 1 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/333 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
|
Cardiac disorders
Cardiovascular
|
0.58%
1/173 • Number of events 1 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.30%
1/333 • Number of events 1 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.66%
2/304 • Number of events 2 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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 |
Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch
n=173 participants at risk
Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch
Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch.
Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
|
Pre-Quit Nicotine Patch
n=156 participants at risk
Pre-Quit Nicotine Patch
Participants randomized to this condition received Pre-Quit Nicotine Patch.
Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day.
|
Pre-Quit Nicotine Gum
n=166 participants at risk
Pre-Quit Nicotine Gum
Participants randomized to this condition received Pre-Quit Nicotine Gum.
Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day.
|
No Pre-Quit Nicotine Patch Nor Gum
n=142 participants at risk
No Pre-Quit Nicotine Patch nor Gum
Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum.
|
Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=304 participants at risk；n=333 participants at risk
Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum
Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt.
|
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
n=333 participants at risk；n=304 participants at risk
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Indigestion
|
2.3%
4/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.64%
1/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
6.0%
10/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
2.6%
8/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
1.5%
5/333 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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
|
7.5%
13/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
5.1%
8/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
7.2%
12/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
4.9%
15/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
6.0%
20/333 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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
|
3.5%
6/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
11/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
0.60%
1/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
7.6%
23/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
7.8%
26/333 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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
Vivid Dreams
|
9.8%
17/173 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
11/156 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
1.2%
2/166 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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%
0/142 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
6.2%
19/304 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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.
|
4.2%
14/333 • AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 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