| ID | Type | Description | Link |
|---|---|---|---|
| R01CA206058 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight.
This is a randomized clinical trial of the efficacy of a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+) plus transdermal nicotine (TN) compared to standard smoking cessation counseling (SC) plus TN in treatment-seeking smokers. After completing an Intake Visit (~week -3), eligible smokers will be randomized (stratified by nicotine dependence, BMI and gender) to participate in 8 individual sessions of BAS+ or SC over a 10-week treatment period with two sessions prior to the target quit date (weeks -2, -1) and six sessions post-target quit date (TQD [week 0] and weeks 1, 2, 4, 6, and 8). Standard, 8-week; open-label TN will begin on the TQD. Moderators will be assessed pre-treatment. Mediating mechanisms will be assessed before, during, and at the end of treatment (EOT, week 8). Smoking will be assessed by self-report and biochemically confirmed (Carbon Monoxide [CO] < 5) at all in-center visits after quitting, at EOT (week 8), and at the 12- and 26-week follow-ups. Weight will be assessed at these same time points. Food intake will be measured by three consecutive days of 24-hour food recalls at Baseline [week -2] and 4-, 8-, and 12- and 26-weeks post-TQD. Smoking cessation and post-cessation weight gain (PCWG) are the primary outcomes and food intake is a secondary outcome at 26-weeks post-TQD. Consistent with intent-to-treat (ITT) analyses, the investigators will measure smoking cessation and weight gain in the full sample at the 26-week follow-up, evaluating a smoking status by treatment interaction for the PCWG analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAS+ | Experimental | Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+). |
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| SC | Placebo Comparator | Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAS+ | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | 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. | Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) |
| Weight Change | 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. | 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) |
| Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date | 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. | 12-Week Follow-Up Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Food Intake | 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). |
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Inclusion Criteria:
Exclusion Criteria:
Smoking Behavior.
Alcohol and Drug.
Medical.
Galactosemia, Notable milk allergy (lactose intolerant participants may proceed unless they experience severe symptoms), Notable soy allergy, Peanut allergy
Psychiatric.
Medication.
Current use or recent discontinuation (within the last 14 days) of:
Current use of:
Daily use of:
General Exclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Janet Audrain-McGovern, Ph.D. | Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36739753 | Derived | Audrain-McGovern J, Wileyto EP, Ashare R, Albelda B, Manikandan D, Perkins KA. Behavioral activation for smoking cessation and the prevention of smoking cessation-related weight gain: A randomized trial. Drug Alcohol Depend. 2023 Mar 1;244:109792. doi: 10.1016/j.drugalcdep.2023.109792. Epub 2023 Feb 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Cessation | 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. | Posted | Count of Participants | Participants | Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) |
|
6 months
Serious Adverse Events were defined as any severe or serious medical event definitely related to study participation.
Adverse Events were defined as any unanticipated medical event definitely related to study participation.
Only Serious and Other Adverse events related to participating in the fMRI scans were monitored/assessed in the sub-study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Activation | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry | Perelman School of Medicine, University of Pennsylvania | (215) 746-7145 | audrain@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Full Study and Sub-Study | Aug 14, 2020 | Oct 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2020 | Oct 21, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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|
| SC | Behavioral | 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. |
|
| Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) |
| Sub-Study: fMRI BOLD Signal Change | 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. | Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 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. | Count of Participants | Participants |
|
| Education | 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. | Count of Participants | Participants |
|
| Income | 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. | Count of Participants | Participants |
|
| Cigarettes per day | 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. | Mean | Standard Deviation | cigarettes per day |
|
| Weight | Mean | Standard Deviation | lbs |
|
| Total kcals | 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. | Mean | Standard Deviation | kcals |
|
| Body mass index | Body Mass Index (BMI) is a measure of body fat based on height and weight. It is derived by dividing weight by height squared (kg/m2). Below 18.5 is underweight, 18.5 - 24.9 is a healthy weight, 25.0 - 29.9 is Overweight, and 30.0 and above is obesity. | Mean | Standard Deviation | kg/m^2 |
|
| Nicotine dependence | Fagerstrom Test for Nicotine Dependence. The Fagerstrom Test for Nicotine Dependence (FTND) is a 6-item measure with good internal consistency (α = .64) and high test-retest reliability (r = .88). Scores range from 0-8 with higher scores indicating greater nicotine dependence. The range for the SC group and the BAS group was 0-8. | 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. | Mean | Standard Deviation | units on a scale |
|
| Substitute reinforcers | Substitute reinforcers were measured by the adapted Pleasant Events Schedule, designed to assess reinforcers that occur in the natural environment. Each participant rated the 78 events once in terms of frequency (0 = none to 2 = often) and once in terms of enjoyability (0 = none to 2 = very) over a specified number of days, yielding a frequency score and an enjoyability score. The cross-product is the reinforcement from the activity. Summing the cross-products, higher scores indicated greater substitute reinforcers. Scores ranged from 0 to 165 (all), 0 to 118 (BAS), and 0 to 165 (SC). | 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. | Mean | Standard Deviation | Score on a scale |
|
| Weight concerns | Weight concerns associated with quitting smoking. These concerns were measured with a reliable (α=.87) and valid 6-item scale. The items were averaged for a total score (1=not at all to 10= very much), with higher scores indicating greater concerns. The range was 1-10 (all), 1.17-10 (SC), and 1-10 (BAS). | 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. | Mean | Standard Deviation | score on a scale |
|
| Depression Symptoms: Sub-Study | The 20-item Center for Epidemiologic Studies Depression Scale was used to measure depression symptoms. Likert-style response options range from 0 to 3, with a potential score range of 0 to 60. Higher scores indicate greater depression symptoms. | 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. | Mean | Standard Deviation | units on a scale |
|
| Relative Reinforcement: Sub Study | Participants chose between a low-effort $ reward and either a food or a $ reward of higher value and effort. Each trial presented a choice between a standard reward (27 button clicks for $0.25) or exerting greater effort to earn a higher value food or $ reward. There were 50 trials for each $ and food (participants could work 0-50 trials for either food or $), with a greater number of trials for food indicative of a higher reinforcing value of food. | 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. | Mean | Standard Deviation | trials |
|
| Complementary Reinforcers: Sub-Study | Complementary reinforcers (CRs) were measured by the adapted Pleasant Events Schedule, assessing reinforcers in the natural environment. These are reinforcers associated with smoking. The 78 events were rated once in frequency (0=none to 2=often) and once in enjoyability (0=none to 2=very), yielding frequency and enjoyability scores. The cross-product of enjoyability x frequency were summed, with higher scores indicating greater CRs. The possible range was 0-312. | 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. | Mean | Standard Deviation | units on a scale |
|
| Disinhibition: Sub-Study | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Behavioral Activation | 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. |
|
|
| Primary | Weight Change | 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. | Posted | Mean | Standard Deviation | Pounds | 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) |
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|
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| Primary | Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date | 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. | 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. | Posted | Count of Participants | Participants | No | 12-Week Follow-Up Visit |
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| Secondary | Food Intake | 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). | 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. | Posted | Mean | Standard Deviation | kcals/day | Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) |
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| Secondary | Sub-Study: fMRI BOLD Signal Change | 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. | 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. | Posted | Mean | Standard Deviation | percentage of signal change | Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8) |
|
|
|
| 0 |
| 142 |
| 0 |
| 142 |
| 0 |
| 142 |
| EG001 | Standard Counseling | 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. | 0 | 146 | 0 | 146 | 0 | 146 |
| EG002 | Sub-Study: Behavioral Activation | As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+). | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Sub-Study: Standard Counseling | As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC). | 0 | 28 | 0 | 28 | 0 | 28 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Unknown or not reported |
|
| White |
|
| Unknown or not reported |
|
| College Graduate |
|
| Some College |
|
| College Graduate |
|
| > $50,000 |
|
| $20,000 - $50,000 |
|
| > $50,000 |
|
| Sub-Study Participants |
|
|