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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: December 2020
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.
- Behavioral: 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.
- Behavioral: 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.
Arms, Groups and Cohorts
- Experimental: BAS+
- Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
- Placebo Comparator: SC
- Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
Clinical Trial Outcome Measures
- Weight Change
- 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)
- 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.
- Smoking Cessation
- Time Frame: 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.
- Food Intake
- 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)
- 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).
Participating in This Clinical Trial
- 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.
- 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.
- 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
- 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.
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.
- 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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Pennsylvania
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Janet Audrain-McGovern, Ph.D., Principal Investigator, Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
- Overall Contact(s)
- Benjamin F Albelda, B.S., 215-746-7173, firstname.lastname@example.org
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