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Completed

NCT Number: NCT03897439

Individualizing Pharmacotherapy for African American Smokers

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Swope Health Central

Kansas City, Missouri, 64130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

Drug

Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.

Other names: Nicoderm

varenicline tartrate

Drug

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.

Other names: Chantix

bupropion

Drug

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.

Other names: Zyban, Wellbutrin

Primary outcomes

  1. Number of Participants With Biochemically Verified Smoking Abstinence at Week 12

    Time frame: Week 12

    Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.

Secondary outcomes

  1. Number of Participants With Biochemically Verified Smoking Abstinence at Week 18

    Time frame: Week 18

    Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers

  2. Number of Participants With Biochemically Verified Smoking Abstinence at Week 26

    Time frame: Week 26

    Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 1, 2019
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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