Recruiting
Phase 3

Extended Treatment

Sponsor:

University of Kansas Medical Center

Code:

NCT05732272

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Bupropion

Study Details

Brief summary:

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

Conditions

Smoking Cessation

Study ID

NCT05732272

Start date

Feb 28, 2023

Status verified date

Feb, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Bupropion

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

Primary outcome measure

  • Verified abstinence at Month 6 [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Tricia Snow, MPH

816-398-8960psnow@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Missouri, United States, 64130

Contacts

Tricia Snow, MPH

816-398-8960psnow@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-02-23.