Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment

Study Overview
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Brief Summary
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This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.

Detailed Description
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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.

Official Title
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Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Bupropion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment<br>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. | Drug: Bupropion<br>* 150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.<br>|
| Active Comparator: Extended Treatment<br>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. | Drug: Bupropion<br>* 150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verified abstinence at Month 6 | Participants receiving extended bupropion treatment will have significantly higher Month 6 verified point-prevalence abstinence than participants receiving standard bupropion treatment. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to medication | We will evaluate the concordance of a biological sample of bupropion level, observable pill count, and 3-day recall as measurements of medication adherence. | Week 4 |