Individualizing Pharmacotherapy for African American Smokers

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897439
• Other study ID #: Study0000142310
• Secondary ID: R01DA046576
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: January 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	Swope Health Central	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Biochemically Verified Smoking Abstinence at 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.	Week 12
Secondary	Number of Participants With Biochemically Verified Smoking Abstinence at 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	Week 18
Secondary	Number of Participants With Biochemically Verified Smoking Abstinence at 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	Week 26