Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain

NCT02906787 | Completed Results

• 2 other identifiers: 825425R01CA206058
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Weight Loss

Keywords

Smoking Cessation; Weight Loss

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• 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)

• Sub-Study: fMRI BOLD Signal Change

  Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8)

Study Arms (2)

BAS+

EXPERIMENTAL

Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).

Behavioral: BAS+

SC

PLACEBO COMPARATOR

Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).

Behavioral: SC

Interventions

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.

BAS+

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.

SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 36739753 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Weight Loss

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry
• Organization: Perelman School of Medicine, University of Pennsylvania

audrain@pennmedicine.upenn.edu

(215) 746-7145

Study Officials

• Janet Audrain-McGovern, Ph.D.

  Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 20, 2016
• Study Start: September 13, 2016
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: May 29, 2024
• Results First Posted: February 16, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)