Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment

Smoking Cessation Clinical Trial

— (KISV)  

Official title:

Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732272
• Other study ID #: STUDY00148037
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: February 2024
• Source: University of Kansas Medical Center
• Contact: Tricia Snow, MPH
• Phone: 816-398-8960
• Email: psnow[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 30, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• African American

• age >18 years

• interested in quitting

• smoked >1 cpd for >1 years

• 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.

• 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

• other smoker in household enrolled in the study.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Bupropion
150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verified abstinence at Month 6	Participants receiving extended bupropion treatment will have significantly higher Month 6 verified point-prevalence abstinence than participants receiving standard bupropion treatment.	Month 6
Secondary	Adherence to medication	We will evaluate the concordance of a biological sample of bupropion level, observable pill count, and 3-day recall as measurements of medication adherence.	Week 4