N/A
N=288
Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain
Smoking Cessation · Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT02906787 ↗Enrolled (actual)
288
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Smoking Cessation — 25; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BAS+ (Behavioral); SC (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Cessation |
25; 33 | — |
| PRIMARY Weight Change |
2.71; 2.00 | — |
| PRIMARY Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date |
9; 10 | — |
| SECONDARY Food Intake |
-156.3; -128.2; -201.85; 121.78 | — |
| SECONDARY Sub-Study: fMRI BOLD Signal Change |
0.3318; -0.0003 | — |
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.
Eligibility Criteria
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 - determine
Data sourced from ClinicalTrials.gov (NCT02906787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.