Smoking Cessation, Weight Loss
Conditions
Keywords
Smoking Cessation, Weight Loss
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBAS+
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.
BEHAVIORALSC
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.
Sponsors
National Cancer Institute (NCI)
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months. * Plan to live in the area for the duration of the study (i.e. \ 30 weeks/8 months). * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. * Smokers who wish to make a permanent quit attempt in the next 1-2 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. * Able to communicate fluently in English (i.e. speaking, writing, and reading). * Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 5 parts per million (ppm) at the Intake Visit.
Exclusion criteria
Smoking Behavior. * Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes and the study-provided TN for the duration of trial will be considered eligible. * Current enrollment or plans to enroll in another research and/or smoking cessation program over the duration of the study (i.e. \ 30 weeks/8 months). * Anticipated use (within the next \ 30 weeks/8 months) of any nicotine substitutes and/or smoking cessation treatments/medications unless provided through the study. * Provide a CO breath test reading less than 8 ppm at Intake Visit. Alcohol and Drug. * History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol. * Current alcohol consumption that exceeds 25 standard drinks/week. * Breath alcohol reading (BrAC) greater than .000 at the Intake Visit. * A positive urine drug screen (UDS) for cocaine, opiates, amphetamines, methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines, methadone, and/or oxycodone at the Intake Visit. Medical. * Women who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. Women must agree to use an adequate form of contraception or abstain from sexual intercourse for the duration and for at least one month after the end of the study. * Current treatment of cancer or diagnosed with cancer (except basal or squamous-cell carcinoma not treated with chemotherapy and/or radiation) in the past 6 months. * Poorly controlled, brittle, or pump-dependent Type I diabetes. * Current peptic ulcer bleeding. * Allergy to adhesive tape. * Skin problems or sensitivities. Eligibility will be evaluated on a case-by-case basis by the Study Physician. * Active hepatitis or poorly controlled kidney and/or liver disease. * Uncontrolled hypertension (systolic blood pressure \[SBP\] greater than 159 and/or diastolic blood pressure \[DBP\] greater than 99 * History of abnormal heart rhythms, tachycardia, and/or cardiovascular disease (e.g. stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case-by-case basis by the Study Physician. * History of epilepsy or seizures. Eligibility will be evaluated on a case-by-case basis by the Study Physician. * Serious or unstable disease within the past 6 months. Notable diseases will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician. * Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician. * Low or borderline intellectual functioning - determined by receiving a score of less than 75 on the Shipley Institute of Living Scale (SILS), which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test. * Applicable food allergies or disorders: Galactosemia, Notable milk allergy (lactose intolerant participants may proceed unless they experience severe symptoms), Notable soy allergy, Peanut allergy Psychiatric. * Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer (may be stable on antidepressant medications), are eligible. * Lifetime history of a suicide attempt. * Lifetime history of schizophrenia, psychosis, and/or bipolar disorder. Medication. Current use or recent discontinuation (within the last 14 days) of: * Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin Standard-Release, Chantix). * Anti-psychotic medications. * Prescription stimulants (e.g., Provigil, Ritalin, Adderall). * Systemic steroids. Current use of: * Nicotine replacement therapy (NRT). * Heart medications such as digoxin, quinidine, and nitroglycerin. Daily use of: * Opiate-containing medications for chronic pain. * Inhaled corticosteroids. * Benzodiazepines and/or Barbiturates. General Exclusion. * Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician. * Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen. * Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study. * Subjects failing to complete an in-person Baseline Visit will be excluded (no Principal Investigator determination required).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | 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. |
| Weight Change | 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. |
| Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date | 12-Week Follow-Up Visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Intake | Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) | 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: fMRI BOLD Signal Change | Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 142 |
| 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. | 146 |
| Total | 288 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missed | 24 | 22 |
| Overall Study | Withdrawal by Subject | 12 | 10 |
Baseline characteristics
| Characteristic | Standard SC | BAS+ | Total |
|---|---|---|---|
| Age, Continuous Main Study Participants | 45.97 years STANDARD_DEVIATION 12.01 | 46.01 years STANDARD_DEVIATION 12.3 | 45.99 years STANDARD_DEVIATION 12.13 |
| Age, Continuous Sub-Study Participants | 42.32 years STANDARD_DEVIATION 10.49 | 45.56 years STANDARD_DEVIATION 12.66 | 44.11 years STANDARD_DEVIATION 11.75 |
| Body mass index | 29.35 kg/m^2 STANDARD_DEVIATION 6.92 | 29.53 kg/m^2 STANDARD_DEVIATION 7.38 | 29.44 kg/m^2 STANDARD_DEVIATION 7.13 |
| Cigarettes per day Main Study Participants | 14.33 cigarettes per day STANDARD_DEVIATION 7.61 | 14.18 cigarettes per day STANDARD_DEVIATION 6.36 | 14.25 cigarettes per day STANDARD_DEVIATION 7.01 |
| Cigarettes per day Sub-Study Participants | 11.44 cigarettes per day STANDARD_DEVIATION 3.67 | 13.33 cigarettes per day STANDARD_DEVIATION 5.42 | 12.51 cigarettes per day STANDARD_DEVIATION 4.75 |
| Complementary Reinforcers: Sub-Study | 31.53 units on a scale STANDARD_DEVIATION 31.15 | 54.20 units on a scale STANDARD_DEVIATION 28.17 | 44.39 units on a scale STANDARD_DEVIATION 29.16 |
| Depression Symptoms: Sub-Study | 13.74 units on a scale STANDARD_DEVIATION 7.96 | 11.40 units on a scale STANDARD_DEVIATION 9.12 | 12.41 units on a scale STANDARD_DEVIATION 8.58 |
| Disinhibition: Sub-Study | 10.79 units on a scale STANDARD_DEVIATION 4.14 | 8.96 units on a scale STANDARD_DEVIATION 3.45 | 9.75 units on a scale STANDARD_DEVIATION 3.78 |
| Education Main Study Participants College Graduate | 38 Participants | 36 Participants | 74 Participants |
| Education Main Study Participants HS Graduate or less | 54 Participants | 51 Participants | 105 Participants |
| Education Main Study Participants Some College | 54 Participants | 55 Participants | 109 Participants |
| Education Sub-Study Participants College Graduate | 5 Participants | 11 Participants | 16 Participants |
| Education Sub-Study Participants HS Graduate or less | 4 Participants | 8 Participants | 12 Participants |
| Education Sub-Study Participants Some College | 10 Participants | 6 Participants | 16 Participants |
| Income Main Study Participants < $20,000 | 45 Participants | 54 Participants | 99 Participants |
| Income Main Study Participants $20,000 - $50,000 | 73 Participants | 57 Participants | 130 Participants |
| Income Main Study Participants > $50,000 | 28 Participants | 31 Participants | 59 Participants |
| Income Sub-Study Participants < $20,000 | 8 Participants | 8 Participants | 16 Participants |
| Income Sub-Study Participants $20,000 - $50,000 | 6 Participants | 8 Participants | 14 Participants |
| Income Sub-Study Participants > $50,000 | 5 Participants | 9 Participants | 14 Participants |
| Nicotine dependence Main Study Participants | 4.97 units on a scale STANDARD_DEVIATION 1.79 | 4.75 units on a scale STANDARD_DEVIATION 1.97 | 4.86 units on a scale STANDARD_DEVIATION 1.88 |
| Nicotine dependence Sub-Study Participants | 4.68 units on a scale STANDARD_DEVIATION 1.92 | 4.12 units on a scale STANDARD_DEVIATION 1.92 | 4.36 units on a scale STANDARD_DEVIATION 2.4 |
| Race/Ethnicity, Customized Main Study Participants Black/African American | 86 Participants | 85 Participants | 171 Participants |
| Race/Ethnicity, Customized Main Study Participants Unknown or not reported | 10 Participants | 6 Participants | 16 Participants |
| Race/Ethnicity, Customized Main Study Participants White | 50 Participants | 51 Participants | 101 Participants |
| Race/Ethnicity, Customized Sub-Study Participants Black/African American | 8 Participants | 11 Participants | 19 Participants |
| Race/Ethnicity, Customized Sub-Study Participants Unknown or not reported | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Sub-Study Participants White | 8 Participants | 14 Participants | 22 Participants |
| Relative Reinforcement: Sub Study | 13.4 trials STANDARD_DEVIATION 19.3 | 6.19 trials STANDARD_DEVIATION 11.71 | 9.34 trials STANDARD_DEVIATION 15.95 |
| Sex: Female, Male Main Study Participants Female | 62 Participants | 57 Participants | 119 Participants |
| Sex: Female, Male Main Study Participants Male | 84 Participants | 85 Participants | 169 Participants |
| Sex: Female, Male Sub-Study Participants Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Sub-Study Participants Male | 12 Participants | 15 Participants | 27 Participants |
| Substitute reinforcers Main Study Participants | 40.43 Score on a scale STANDARD_DEVIATION 32.8 | 41.31 Score on a scale STANDARD_DEVIATION 27.25 | 40.86 Score on a scale STANDARD_DEVIATION 30.14 |
| Substitute reinforcers Sub-Study Participants | 55.53 Score on a scale STANDARD_DEVIATION 42.33 | 39.68 Score on a scale STANDARD_DEVIATION 30.82 | 46.57 Score on a scale STANDARD_DEVIATION 35.8 |
| Total kcals Main Study Participants | 2319.30 kcals STANDARD_DEVIATION 781.62 | 2304.47 kcals STANDARD_DEVIATION 1022.95 | 2311.97 kcals STANDARD_DEVIATION 907.43 |
| Total kcals Sub-Study Participants | 2506.78 kcals STANDARD_DEVIATION 779.87 | 2596.66 kcals STANDARD_DEVIATION 1261.55 | 2563.79 kcals STANDARD_DEVIATION 1072.38 |
| Weight | 191.43 lbs STANDARD_DEVIATION 47.97 | 191.71 lbs STANDARD_DEVIATION 50.73 | 191.57 lbs STANDARD_DEVIATION 49.26 |
| Weight concerns Main Study Participants | 4.98 score on a scale STANDARD_DEVIATION 2.13 | 4.72 score on a scale STANDARD_DEVIATION 2.24 | 4.85 score on a scale STANDARD_DEVIATION 2.18 |
| Weight concerns Sub-Study Participants | 4.70 score on a scale STANDARD_DEVIATION 2.2 | 4.70 score on a scale STANDARD_DEVIATION 2.07 | 4.70 score on a scale STANDARD_DEVIATION 2.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 142 | 0 / 146 | 0 / 31 | 0 / 28 |
| other Total, other adverse events | 0 / 142 | 0 / 146 | 0 / 31 | 0 / 28 |
| serious Total, serious adverse events | 0 / 142 | 0 / 146 | 0 / 31 | 0 / 28 |
Outcome results
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.
Time frame: Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Counseling | Smoking Cessation | 25 Participants |
| Behavioral Activation | Smoking Cessation | 33 Participants |
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.
Time frame: 12-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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Counseling | Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date | 9 Participants |
| Behavioral Activation | Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date | 10 Participants |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Counseling | Weight Change | 2.71 Pounds | Standard Deviation 12.46 |
| Behavioral Activation | Weight Change | 2.00 Pounds | Standard Deviation 10.64 |
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Counseling | Food Intake | Main Study Participants | -156.3 kcals/day | Standard Deviation 769.44 |
| Standard Counseling | Food Intake | Sub-Study Participants | -201.85 kcals/day | Standard Deviation 553.74 |
| Behavioral Activation | Food Intake | Sub-Study Participants | 121.78 kcals/day | Standard Deviation 1322.42 |
| Behavioral Activation | Food Intake | Main Study Participants | -128.2 kcals/day | Standard Deviation 943.62 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Counseling | Sub-Study: fMRI BOLD Signal Change | 0.3318 percentage of signal change | Standard Deviation 0.22944 |
| Behavioral Activation | Sub-Study: fMRI BOLD Signal Change | -0.0003 percentage of signal change | Standard Deviation 0.223 |