Smoking Cessation
Conditions
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.
Interventions
DRUGBupropion
150 mg once daily for 3 days, then twice daily for the remainder of the treatment phase.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verified abstinence at Month 6 | Month 6 | Participants receiving extended bupropion treatment will have significantly higher Month 6 verified point-prevalence abstinence than participants receiving standard bupropion treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to medication | 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. |
Countries
United States
Contacts
CONTACTTricia Snow, MPH
PRINCIPAL_INVESTIGATORLisa Sanderson Cox, PhD
University of Kanas Medical Center
Outcome results
None listed