NCT05732272

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
12mo left

Started Feb 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Feb 2023Apr 2027

First Submitted

Initial submission to the registry

February 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

February 7, 2023

Last Update Submit

February 19, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adherence to medication

    Week 4

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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

Extended Treatment

ACTIVE COMPARATOR

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

Interventions

BupropionDRUG

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

Extended TreatmentStandard Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 64130, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Lisa Sanderson Cox, PhD

    University of Kanas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tricia Snow, MPH

CONTACT

816-398-8960psnow@kumc.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 17, 2023

Study Start

February 28, 2023

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)