Phase 4 N=540 Randomized Triple-blind Treatment

Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking

Bladder Cancer · Cervical Cancer · Esophageal Cancer · Gastric Cancer · Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00666978 ↗

Enrolled (actual)

540

Serious AEs

3.9%

Results posted

Jul 2017

Primary outcome: Primary: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months — 36; 27 Participants — p=.23

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: smoking cessation intervention (Behavioral); bupropion hydrochloride (Drug); gene expression analysis (Genetic); polymerase chain reaction (Genetic); counseling intervention (Other); educational intervention (Other); psychosocial assessment and care (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lisa Sanderson Cox, PhD
Primary completion: Jun 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00666978). 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.