Phase 4
Completed N=540
Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking
Source: ClinicalTrials.gov NCT00666978 ↗Enrolled (actual)
540
Serious AEs
3.9%
Results posted
Jul 2017
Primary outcomePrimary: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months — 36; 27 Participants — p=.23
◆ Published Evidence
Highly cited
112citations · ~22 / year
Interventions for preventing weight gain after smoking cessation.
Summary
RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may help African-American smokers stop smoking. It is not yet known whether health education counseling is more effective with or without bupropion in helping African Americans stop smoking.
PURPOSE: This clinical trial is studying health education counseling and bupropion to see how well they work compared with a placebo and health education counseling in helping African Americans smokers stop smoking.
Linked Publications (5)
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Interventions for preventing weight gain after smoking cessation.
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Antidepressants for smoking cessation.
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Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations.
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Factors associated with discontinuation of bupropion and counseling among African American light smokers in a randomized clinical trial.
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Does sex alter the relationship between CYP2B6 variation, hydroxybupropion concentration and bupropion-aided smoking cessation in African Americans? A moderated mediation analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months |
36; 27 | .23 |
| SECONDARY Number of Slow and Fast Metabolizers by Metabolite Ratio |
236; 214 | 0.0022 sig |
| SECONDARY Number of Participants for Each CYP2B6 Allele |
2; 6; 95; 0; 0; 17 | <0.05 sig |
| SECONDARY Number of Slow and Fast Metabolizers by Genotype |
265; 269 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month
- Not a heavy smoker
- No other forms of tobacco within the past 30 days
- Must be interested in stopping smoking
- No other smoker in the household enrolled in this study
PATIENT CHARACTERISTICS:
- Has a home address and a functioning telephone number
- Not planning to move from the Kansas City metro area within the next 12 months
- Not pregnant or nursing
- Negative pregnancy test
- No alcohol or substance abuse within the past year
- Not currently drinking ≥ 14 alcoholic drinks per week
- No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month
- No history of seizures or head trauma
- No history of bulimia or anorexia nervosa
- No myocardial infarction within the past 30 days
- No reported use of opiates, cocaine, or stimulants
- No diabetes requiring oral hypoglycemics or insulin
PRIOR CONCURRENT THERAPY:
- More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin
- No other concurrent medication that contains bupropion hydrochloride
- No concurrent psychoactive medications
Data sourced from ClinicalTrials.gov (NCT00666978) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.