Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupropion.
- Who it may be relevant to
- Registry conditions: Smoking Cessation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Bupropion
150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.
Primary outcome measures
- Verified abstinence at Month 6 [Time frame: Month 6]
Secondary outcome measures (1)
- Adherence to medication [Time frame: Week 4]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT05732272 · STUDY00148037