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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Bupropion

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tricia Snow, MPH; Phone Number: 816-398-8960; Email: psnow@kumc.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64130
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Tricia Snow, MPH; Phone Number: 816-398-8960; Email: psnow@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Treatment; 250 participants will be randomly assigned to the standard treatment arm and receive 7 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 7 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines.	Drug: Bupropion; 150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.
Active Comparator: Extended Treatment; 250 participants will be randomly assigned to the extended treatment arm and receive 24 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 24 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines.	Drug: Bupropion; 150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Lisa Sanderson Cox, PhD, University of Kanas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Organic Chemicals; Ketones; Propiophenones; Bupropion
• Other Study ID Numbers: STUDY00148037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No