Trial Outcomes & Findings for Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain (NCT NCT02906787)
NCT ID: NCT02906787
Last Updated: 2024-05-29
Results Overview
Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 8), at 12 and 26 weeks after the target quit date. The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by CO \< 5 ppm at End of Treatment (week 8), and by saliva cotinine \< 15ng/ml at the 12- and 26-week follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
288 participants
Primary outcome timeframe
Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
Results posted on
2024-05-29
Participant Flow
Participant milestones
| Measure |
BAS+
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
Standard SC
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
146
|
|
Overall Study
EOT
|
106
|
112
|
|
Overall Study
3-month Follow-up
|
106
|
114
|
|
Overall Study
Enrolled in Neuroimaging Sub-study
|
31
|
28
|
|
Overall Study
Neuroimaging Sub-study: Completed Scan 1
|
30
|
26
|
|
Overall Study
Neuroimaging Sub-study: Completed Scan 2
|
25
|
20
|
|
Overall Study
Neuroimaging Sub-study: Completed EOT
|
25
|
20
|
|
Overall Study
Neuroimaging Sub-study: Completed 12-Week Follow-up
|
25
|
20
|
|
Overall Study
Completed Neuroimaging Sub-study
|
25
|
20
|
|
Overall Study
COMPLETED
|
106
|
114
|
|
Overall Study
NOT COMPLETED
|
36
|
32
|
Reasons for withdrawal
| Measure |
BAS+
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
Standard SC
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
10
|
|
Overall Study
Missed
|
24
|
22
|
Baseline Characteristics
Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
Baseline characteristics by cohort
| Measure |
BAS+
n=142 Participants
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
Standard SC
n=146 Participants
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Main Study Participants
|
46.01 years
STANDARD_DEVIATION 12.30 • n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
45.97 years
STANDARD_DEVIATION 12.01 • n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
45.99 years
STANDARD_DEVIATION 12.13 • n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Age, Continuous
Sub-Study Participants
|
45.56 years
STANDARD_DEVIATION 12.66 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
42.32 years
STANDARD_DEVIATION 10.49 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
44.11 years
STANDARD_DEVIATION 11.75 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Sex: Female, Male
Main Study Participants · Female
|
57 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
62 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
119 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Sex: Female, Male
Main Study Participants · Male
|
85 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
84 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
169 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Sex: Female, Male
Sub-Study Participants · Female
|
10 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
7 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
17 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Sex: Female, Male
Sub-Study Participants · Male
|
15 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
12 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
27 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Race/Ethnicity, Customized
Main Study Participants · Black/African American
|
85 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
86 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
171 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Race/Ethnicity, Customized
Main Study Participants · White
|
51 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
50 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
101 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Race/Ethnicity, Customized
Main Study Participants · Unknown or not reported
|
6 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
10 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
16 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Race/Ethnicity, Customized
Sub-Study Participants · Black/African American
|
11 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
8 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
19 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Race/Ethnicity, Customized
Sub-Study Participants · White
|
14 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
8 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
22 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Race/Ethnicity, Customized
Sub-Study Participants · Unknown or not reported
|
0 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
3 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
3 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Education
Main Study Participants · HS Graduate or less
|
51 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
54 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
105 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Education
Main Study Participants · Some College
|
55 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
54 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
109 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Education
Main Study Participants · College Graduate
|
36 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
38 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
74 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Education
Sub-Study Participants · HS Graduate or less
|
8 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
12 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Education
Sub-Study Participants · Some College
|
6 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
10 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
16 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Education
Sub-Study Participants · College Graduate
|
11 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
5 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
16 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Income
Main Study Participants · < $20,000
|
54 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
45 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
99 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Income
Main Study Participants · $20,000 - $50,000
|
57 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
73 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
130 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Income
Main Study Participants · > $50,000
|
31 Participants
n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
28 Participants
n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
59 Participants
n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Income
Sub-Study Participants · < $20,000
|
8 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
8 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
16 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Income
Sub-Study Participants · $20,000 - $50,000
|
8 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
6 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
14 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Income
Sub-Study Participants · > $50,000
|
9 Participants
n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
5 Participants
n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
14 Participants
n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Cigarettes per day
Main Study Participants
|
14.18 cigarettes per day
STANDARD_DEVIATION 6.36 • n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
14.33 cigarettes per day
STANDARD_DEVIATION 7.61 • n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
14.25 cigarettes per day
STANDARD_DEVIATION 7.01 • n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Cigarettes per day
Sub-Study Participants
|
13.33 cigarettes per day
STANDARD_DEVIATION 5.42 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
11.44 cigarettes per day
STANDARD_DEVIATION 3.67 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
12.51 cigarettes per day
STANDARD_DEVIATION 4.75 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Weight
|
191.71 lbs
STANDARD_DEVIATION 50.73 • n=142 Participants
|
191.43 lbs
STANDARD_DEVIATION 47.97 • n=146 Participants
|
191.57 lbs
STANDARD_DEVIATION 49.26 • n=288 Participants
|
|
Total kcals
Main Study Participants
|
2304.47 kcals
STANDARD_DEVIATION 1022.95 • n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
2319.30 kcals
STANDARD_DEVIATION 781.62 • n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
2311.97 kcals
STANDARD_DEVIATION 907.43 • n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Total kcals
Sub-Study Participants
|
2596.66 kcals
STANDARD_DEVIATION 1261.55 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
2506.78 kcals
STANDARD_DEVIATION 779.87 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
2563.79 kcals
STANDARD_DEVIATION 1072.38 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Body mass index
|
29.53 kg/m^2
STANDARD_DEVIATION 7.38 • n=142 Participants
|
29.35 kg/m^2
STANDARD_DEVIATION 6.92 • n=146 Participants
|
29.44 kg/m^2
STANDARD_DEVIATION 7.13 • n=288 Participants
|
|
Nicotine dependence
Main Study Participants
|
4.75 units on a scale
STANDARD_DEVIATION 1.97 • n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.97 units on a scale
STANDARD_DEVIATION 1.79 • n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.86 units on a scale
STANDARD_DEVIATION 1.88 • n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Nicotine dependence
Sub-Study Participants
|
4.12 units on a scale
STANDARD_DEVIATION 1.92 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.68 units on a scale
STANDARD_DEVIATION 1.92 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.36 units on a scale
STANDARD_DEVIATION 2.40 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Substitute reinforcers
Main Study Participants
|
41.31 Score on a scale
STANDARD_DEVIATION 27.25 • n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
40.43 Score on a scale
STANDARD_DEVIATION 32.80 • n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
40.86 Score on a scale
STANDARD_DEVIATION 30.14 • n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Substitute reinforcers
Sub-Study Participants
|
39.68 Score on a scale
STANDARD_DEVIATION 30.82 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
55.53 Score on a scale
STANDARD_DEVIATION 42.33 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
46.57 Score on a scale
STANDARD_DEVIATION 35.80 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Weight concerns
Main Study Participants
|
4.72 score on a scale
STANDARD_DEVIATION 2.24 • n=142 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.98 score on a scale
STANDARD_DEVIATION 2.13 • n=146 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.85 score on a scale
STANDARD_DEVIATION 2.18 • n=288 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Weight concerns
Sub-Study Participants
|
4.70 score on a scale
STANDARD_DEVIATION 2.07 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.70 score on a scale
STANDARD_DEVIATION 2.2 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
4.70 score on a scale
STANDARD_DEVIATION 2.10 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Depression Symptoms: Sub-Study
|
11.40 units on a scale
STANDARD_DEVIATION 9.12 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
13.74 units on a scale
STANDARD_DEVIATION 7.96 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
12.41 units on a scale
STANDARD_DEVIATION 8.58 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Relative Reinforcement: Sub Study
|
6.19 trials
STANDARD_DEVIATION 11.71 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
13.4 trials
STANDARD_DEVIATION 19.3 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
9.34 trials
STANDARD_DEVIATION 15.95 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Complementary Reinforcers: Sub-Study
|
54.20 units on a scale
STANDARD_DEVIATION 28.17 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
31.53 units on a scale
STANDARD_DEVIATION 31.15 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
44.39 units on a scale
STANDARD_DEVIATION 29.16 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
|
Disinhibition: Sub-Study
|
8.96 units on a scale
STANDARD_DEVIATION 3.45 • n=25 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
10.79 units on a scale
STANDARD_DEVIATION 4.14 • n=19 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
9.75 units on a scale
STANDARD_DEVIATION 3.78 • n=44 Participants • Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
|
PRIMARY outcome
Timeframe: Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 8), at 12 and 26 weeks after the target quit date. The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by CO \< 5 ppm at End of Treatment (week 8), and by saliva cotinine \< 15ng/ml at the 12- and 26-week follow-up.
Outcome measures
| Measure |
Standard Counseling
n=146 Participants
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
Behavioral Activation
n=142 Participants
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
|---|---|---|
|
Smoking Cessation
|
25 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Through Study Completion (Intake Visit, Baseline Visit, Pre-Quit Visit , Target Quit Date Visit, Mid-Tx. 1 Visit, Mid-Tx 2 Visit, Mid-Tx 3 Visit, Mid-Tx 4 Visit , End of Treatment, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)Weight will be measured by a physician's scale (pounds) at the beginning of every in-person visit through study completion. Participants will be wearing light clothing without shoes. Pre-cessation weight will be computed as the average of weights at the Intake and Baseline Visits prior to any change in smoking behavior. Weight change from Baseline to the 26-week follow-up will serve as a primary weight outcome variable.
Outcome measures
| Measure |
Standard Counseling
n=146 Participants
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
Behavioral Activation
n=142 Participants
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
|---|---|---|
|
Weight Change
|
2.71 Pounds
Standard Deviation 12.46
|
2.00 Pounds
Standard Deviation 10.64
|
PRIMARY outcome
Timeframe: 12-Week Follow-Up VisitPopulation: Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff for the last 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading \<8 parts per million.
Outcome measures
| Measure |
Standard Counseling
n=19 Participants
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
Behavioral Activation
n=25 Participants
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
|---|---|---|
|
Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)Population: Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
Food intake (secondary outcome) will be assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week and 26-week follow-up Visits (n=15). A trained member of the research staff will use a multi-pass method with an interactive computerized software program, the Automated Self-Administered 24-hour Recall (ASA24®), to determine total kcal/day (outcome variable).
Outcome measures
| Measure |
Standard Counseling
n=146 Participants
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
Behavioral Activation
n=142 Participants
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
|---|---|---|
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Food Intake
Main Study Participants
|
-156.3 kcals/day
Standard Deviation 769.44
|
-128.2 kcals/day
Standard Deviation 943.62
|
|
Food Intake
Sub-Study Participants
|
-201.85 kcals/day
Standard Deviation 553.74
|
121.78 kcals/day
Standard Deviation 1322.42
|
SECONDARY outcome
Timeframe: Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8)Population: Sub-study: Main study participants that meet certain MRI related study criteria may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants receive in the main study. They will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.
T2\*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner.
Outcome measures
| Measure |
Standard Counseling
n=19 Participants
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
|
Behavioral Activation
n=25 Participants
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
|
|---|---|---|
|
Sub-Study: fMRI BOLD Signal Change
|
0.3318 percentage of signal change
Standard Deviation 0.22944
|
-0.0003 percentage of signal change
Standard Deviation 0.2230
|
Adverse Events
Behavioral Activation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub-Study: Behavioral Activation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub-Study: Standard Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry
Perelman School of Medicine, University of Pennsylvania
Phone: (215) 746-7145
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place