Clinical trial NCT05732272: Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
Official title: Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: Verified abstinence at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Adherence to medication
timeFrame: Week 4
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
Study officials:
affiliation: University of Kanas Medical Center
name: Lisa Sanderson Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References: