Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
- Registration Number
- NCT05732272
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.
- Detailed Description
The primary objective of this study is to evaluate extended use of bupropion with the goal of enhancing abstinence in African American daily smokers, including the full spectrum of light, moderate, and heavy smokers. A two-arm, randomized design will be used to evaluate the efficacy of extended (6 months) bupropion treatment compared to standard (7 weeks) bupropion treatment. Baseline randomization stratified by gender and cpd (≤10, \>10cpd) will assign participants (N=500) to receive extended treatment (EXT; 24 weeks of bupropion, n=250) or standard treatment (ST; 7 weeks of bupropion, n=250). All participants will receive culturally-relevant, individualized smoking cessation counseling, including support for medication adherence, and will be followed through Month 12.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- African American
- age >18 years
- interested in quitting
- smoked >1 cpd for >1 years
- smoked on >25 days in the past month
- willing to take 6 months of study medication and complete all visits
- have a home address and functioning telephone number
- Consistent with contraindications for bupropion:
- use of psychoactive medications
- history of alcohol or substance abuse within the past year
- binge drinking (>5 drinks on one occasion) >2 times in the past month
- history of seizures or head trauma; history of bulimia or anorexia nervosa
- pregnant (as measured by over the counter pregnancy test kit for women of child-bearing age only) or contemplating pregnancy; breast feeding
- myocardial infarction in the past 2 months
- reported use of opiates, cocaine, or stimulants
- unstable diabetes
- bupropion is a known inhibitor of the liver enzyme CYP2D6, so those taking drugs known to be higher metabolized by this enzyme (e.g., metoprolol, tamoxifen) will be excluded.
- use of stop smoking medications (bupropion, varenicline, nicotine replacement, fluoxetine, clonidine, buspirone, or doxepin) in the past 30 days
- planning to move from the Kansas City area in the next year
- other smoker in household enrolled in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended Treatment Bupropion 250 participants will be randomly assigned to the extended treatment arm and receive 24 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 24 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines. Standard Treatment Bupropion 250 participants will be randomly assigned to the standard treatment arm and receive 7 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 7 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines.
- Primary Outcome Measures
Name Time Method Verified abstinence at Month 6 Month 6 Participants receiving extended bupropion treatment will have significantly higher Month 6 verified point-prevalence abstinence than participants receiving standard bupropion treatment.
- Secondary Outcome Measures
Name Time Method Adherence to medication Week 4 We will evaluate the concordance of a biological sample of bupropion level, observable pill count, and 3-day recall as measurements of medication adherence.
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Missouri, United States