Individualizing Pharmacotherapy for African American Smokers

• Status: Active, not recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

Summary

Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Bupropion; Nicotine; Varenicline

Criteria

Inclusion Criteria:

• Non-Hispanic African American

• ≥ 18 years of age

• Smoke 5-30 cigarettes per day (CPD)

• Daily cigarette smoker

• Smoked at current rate for > 6 months

• Verified smoker (CO > 5 ppm)

• Functioning telephone

• Interested in quitting smoking

• Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits

Exclusion Criteria:

• Use of non-cigarette tobacco products in past 30 days

• Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year

• Use of pharmacotherapy in the month prior to enrollment

• Pregnant, contemplating getting pregnant, or breastfeeding

• Unstable housing (e.g., street, shelter)

• Plans to move from Kansas City during the treatment and follow-up phase

• Another household member enrolled in the study