Trial Outcomes & Findings for Identifying Treatments to Motivate Smokers to Quit (NCT NCT01122238)
NCT ID: NCT01122238
Last Updated: 2015-12-16
Results Overview
Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model. Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces "average number of cigarettes per day in the past week" (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
517 participants
Primary outcome timeframe
Assessed at week 26 relative to baseline CPD.
Results posted on
2015-12-16
Participant Flow
Participant milestones
| Measure |
1, Nicotine Patch, Nicotine Gum, Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
2, Nicotine Patch, Nicotine Gum, Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
3, Nicotine Patch, Nicotine Gum, No Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
4, Nicotine Patch, Nicotine Gum, No Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
5, Nicotine Patch, No Nicotine Gum, Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
6, Nicotine Patch, No Nicotine Gum, Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
7, Nicotine Patch, No Nicotine Gum, No Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
9, No Nicotine Patch, Nicotine Gum, Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
10, No Nicotine Patch, Nicotine Gum, Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
11, No Nicotine Patch, Nicotine Gum, No Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
13, No Nicotine Patch, No Nicotine Gum, Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
37
|
33
|
33
|
33
|
32
|
35
|
32
|
32
|
34
|
32
|
33
|
30
|
32
|
28
|
31
|
|
Overall Study
COMPLETED
|
28
|
36
|
28
|
33
|
33
|
31
|
34
|
32
|
31
|
33
|
32
|
31
|
28
|
31
|
28
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
5
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
2
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identifying Treatments to Motivate Smokers to Quit
Baseline characteristics by cohort
| Measure |
1, Nicotine Patch, Nicotine Gum, Reduction, MI
n=30 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
2, Nicotine Patch, Nicotine Gum, Reduction, No MI
n=37 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
3, Nicotine Patch, Nicotine Gum, No Reduction, MI
n=33 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
4, Nicotine Patch, Nicotine Gum, No Reduction, No MI
n=33 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
5, Nicotine Patch, No Nicotine Gum, Reduction, MI
n=33 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
6, Nicotine Patch, No Nicotine Gum, Reduction, No MI
n=32 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
7, Nicotine Patch, No Nicotine Gum, No Reduction, MI
n=35 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI
n=32 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
9, No Nicotine Patch, Nicotine Gum, Reduction, MI
n=32 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
10, No Nicotine Patch, Nicotine Gum, Reduction, No MI
n=34 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
11, No Nicotine Patch, Nicotine Gum, No Reduction, MI
n=32 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI
n=33 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
13, No Nicotine Patch, No Nicotine Gum, Reduction, MI
n=30 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI
n=32 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI
n=28 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
|
16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI
n=31 Participants
This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
|
Total
n=517 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
27 Participants
n=36 Participants
|
22 Participants
n=24 Participants
|
26 Participants
n=135 Participants
|
452 Participants
n=136 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
59 Participants
n=136 Participants
|
|
Age, Continuous
|
44.37 years
STANDARD_DEVIATION 13.28 • n=5 Participants
|
46.00 years
STANDARD_DEVIATION 14.05 • n=7 Participants
|
49.18 years
STANDARD_DEVIATION 14.89 • n=5 Participants
|
48.91 years
STANDARD_DEVIATION 13.22 • n=4 Participants
|
47.00 years
STANDARD_DEVIATION 14.03 • n=21 Participants
|
48.47 years
STANDARD_DEVIATION 14.50 • n=8 Participants
|
44.89 years
STANDARD_DEVIATION 14.57 • n=8 Participants
|
47.91 years
STANDARD_DEVIATION 14.19 • n=24 Participants
|
41.63 years
STANDARD_DEVIATION 15.40 • n=42 Participants
|
49.53 years
STANDARD_DEVIATION 13.77 • n=42 Participants
|
45.41 years
STANDARD_DEVIATION 14.89 • n=42 Participants
|
47.30 years
STANDARD_DEVIATION 13.90 • n=42 Participants
|
46.87 years
STANDARD_DEVIATION 14.71 • n=36 Participants
|
47.06 years
STANDARD_DEVIATION 14.98 • n=36 Participants
|
51.93 years
STANDARD_DEVIATION 12.82 • n=24 Participants
|
46.84 years
STANDARD_DEVIATION 15.18 • n=135 Participants
|
47.05 years
STANDARD_DEVIATION 14.33 • n=136 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
18 Participants
n=36 Participants
|
21 Participants
n=36 Participants
|
18 Participants
n=24 Participants
|
19 Participants
n=135 Participants
|
328 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
11 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
189 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
37 participants
n=7 Participants
|
33 participants
n=5 Participants
|
33 participants
n=4 Participants
|
33 participants
n=21 Participants
|
32 participants
n=8 Participants
|
35 participants
n=8 Participants
|
32 participants
n=24 Participants
|
32 participants
n=42 Participants
|
34 participants
n=42 Participants
|
32 participants
n=42 Participants
|
33 participants
n=42 Participants
|
30 participants
n=36 Participants
|
32 participants
n=36 Participants
|
28 participants
n=24 Participants
|
31 participants
n=135 Participants
|
517 participants
n=136 Participants
|
PRIMARY outcome
Timeframe: Assessed at week 26 relative to baseline CPD.Population: Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.
Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model. Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces "average number of cigarettes per day in the past week" (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar.
Outcome measures
| Measure |
Nicotine Patch
n=265 Participants
All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
|
No Nicotine Patch
n=252 Participants
All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
|
Nicotine Gum
n=264 Participants
All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
|
No Nicotine Gum
n=253 Participants
All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
|
Smoking Reduction
n=260 Participants
All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
|
No Smoking Reduction
n=257 Participants
All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
|
Motivational Interviewing
n=253 Participants
All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
|
No Motivational Interviewing
n=264 Participants
All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in Cigarettes Smoked Per Day (CPD)
|
38.7 Percent Change in cigarettes per day
Standard Deviation 36.2
|
38.9 Percent Change in cigarettes per day
Standard Deviation 37.1
|
37.4 Percent Change in cigarettes per day
Standard Deviation 36.2
|
40.2 Percent Change in cigarettes per day
Standard Deviation 36.9
|
38.6 Percent Change in cigarettes per day
Standard Deviation 36.3
|
38.9 Percent Change in cigarettes per day
Standard Deviation 36.9
|
37.2 Percent Change in cigarettes per day
Standard Deviation 35.6
|
40.2 Percent Change in cigarettes per day
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: Assessed at baseline and week 26.Population: Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.
Outcome measures
| Measure |
Nicotine Patch
n=265 Participants
All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
|
No Nicotine Patch
n=252 Participants
All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
|
Nicotine Gum
n=264 Participants
All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
|
No Nicotine Gum
n=253 Participants
All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
|
Smoking Reduction
n=260 Participants
All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
|
No Smoking Reduction
n=257 Participants
All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
|
Motivational Interviewing
n=253 Participants
All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
|
No Motivational Interviewing
n=264 Participants
All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
|
|---|---|---|---|---|---|---|---|---|
|
Average Number of Cigarettes Per Day in the Past Week.
|
.117 Change in cigarettes per day
Standard Deviation 6.688
|
-.123 Change in cigarettes per day
Standard Deviation 6.540
|
.179 Change in cigarettes per day
Standard Deviation 6.402
|
-.187 Change in cigarettes per day
Standard Deviation 6.830
|
-.158 Change in cigarettes per day
Standard Deviation 6.568
|
.160 Change in cigarettes per day
Standard Deviation 6.663
|
.371 Change in cigarettes per day
Standard Deviation 6.597
|
-.353 Change in cigarettes per day
Standard Deviation 6.617
|
Adverse Events
Prequit Combined Nicotine Patch + Gum
Serious events: 2 serious events
Other events: 71 other events
Deaths: 0 deaths
Prequit Nicotine Patch Only
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Prequit Nicotine Gum Only
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
No Medication
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prequit Combined Nicotine Patch + Gum
n=133 participants at risk
Prequit Combined Nicotine Patch + Gum
Participants randomized to this condition received a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks.
|
Prequit Nicotine Patch Only
n=132 participants at risk
Prequit Nicotine Patch Only
Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks.
|
Prequit Nicotine Gum Only
n=131 participants at risk
Prequit Nicotine Gum Only.
Participants randomized to this condition received a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks.
|
No Medication
n=121 participants at risk
No Medication
Participants randomized to this condition received no medication.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiovascular
|
0.75%
1/133 • Number of events 1 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.76%
1/132 • Number of events 1 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
2/131 • Number of events 2 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
General disorders
Death-unknown cause
|
0.75%
1/133 • Number of events 1 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.76%
1/131 • Number of events 1 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.83%
1/121 • Number of events 1 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.83%
1/121 • Number of events 1 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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 |
Prequit Combined Nicotine Patch + Gum
n=133 participants at risk
Prequit Combined Nicotine Patch + Gum
Participants randomized to this condition received a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks.
|
Prequit Nicotine Patch Only
n=132 participants at risk
Prequit Nicotine Patch Only
Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks.
|
Prequit Nicotine Gum Only
n=131 participants at risk
Prequit Nicotine Gum Only.
Participants randomized to this condition received a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks.
|
No Medication
n=121 participants at risk
No Medication
Participants randomized to this condition received no medication.
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
9.0%
12/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
6.8%
9/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Nervous system disorders
Headache
|
10.5%
14/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
11.4%
15/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
3.1%
4/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Gastrointestinal disorders
Indigestion
|
11.3%
15/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
2/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
11.5%
15/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Nervous system disorders
Insomnia
|
9.0%
12/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
13.6%
18/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
2.3%
3/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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
Irregular Heartbeat
|
6.0%
8/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
2/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
2.3%
3/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Skin and subcutaneous tissue disorders
Itches or Hives
|
4.5%
6/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
9.8%
13/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.76%
1/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Gastrointestinal disorders
Mouth Problems
|
3.8%
5/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.76%
1/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
6.1%
8/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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
|
13.5%
18/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
11.4%
15/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
11.5%
15/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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
|
25.6%
34/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
18.2%
24/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
|
Nervous system disorders
VividDreams
|
12.8%
17/133 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
19.7%
26/132 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
|
0.76%
1/131 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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%
0/121 • AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly 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