NCT03897439

Individualizing Pharmacotherapy for African American Smokers

Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \[varenicline (VAR), bupropion (BUP) plus NP, \] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine patch	Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
DRUG	Varenicline Tartrate	VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
DRUG	Bupropion	BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-11-30
• Completion: 2022-01-30
• First posted: 2019-04-01
• Last updated: 2023-04-03
• Results posted: 2023-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study