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

Purpose

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

Condition

  • Smoking Cessation

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard Treatment
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
    150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.
Active Comparator
Extended Treatment
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
    150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Missouri 64130
Contact:
Tricia Snow, MPH
816-398-8960
psnow@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Tricia Snow, MPH
816-398-8960
psnow@kumc.edu

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.