NCT05732272 Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
| NCT ID | NCT05732272 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Kansas Medical Center |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-02-28 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2023-02-28 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.
Eligibility Criteria
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.
Contact & Investigator
Lisa Sanderson Cox, PhD
PRINCIPAL INVESTIGATOR
University of Kanas Medical Center
Frequently Asked Questions
Who can join the NCT05732272 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05732272 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT05732272 currently recruiting?
Yes, NCT05732272 is actively recruiting participants. Contact the research team at psnow@kumc.edu for enrollment information.
Where is the NCT05732272 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT05732272 clinical trial?
NCT05732272 is sponsored by University of Kansas Medical Center. The principal investigator is Lisa Sanderson Cox, PhD at University of Kanas Medical Center. The trial plans to enroll 500 participants.