(KISV): Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Eligible individuals must be self-described African American, age >18 years, interested in quitting, smoked >1 cpd for >1 years and 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. Other exclusions include 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, or other smoker in household enrolled in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kansas Medical Center | Kansas City | Missouri | United States | 64130 |
Sponsors and Collaborators
- University of Kansas Medical Center
Investigators
- Principal Investigator: Lisa Sanderson Cox, PhD, University of Kanas Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00148037