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NCT Number: NCT05732272

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center

Kansas City, Missouri, 64130, United States

Location status: Recruiting

Location contact

Tricia Snow, MPH

CONTACT

[email protected]

816-398-8960

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

bupropion

Drug

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

Primary outcomes

  1. Verified abstinence at Month 6

    Time frame: Month 6

    Participants receiving extended bupropion treatment will have significantly higher Month 6 verified point-prevalence abstinence than participants receiving standard bupropion treatment.

Secondary outcomes

  1. Adherence to medication

    Time frame: Week 4

    We will evaluate the concordance of a biological sample of bupropion level, observable pill count, and 3-day recall as measurements of medication adherence.

Study contacts

Contact information is provided by the study sponsor or research team.

Tricia Snow, MPH

CONTACT

[email protected]

816-398-8960

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: (KISV)

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2023
Registry last updated
Feb 23, 2026

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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