The two purposes of this study are 1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has 1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and 2. on the stimulant effect of bupropion and 2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that...
Date First Received: May 25, 2006
Last Updated: April 7, 2008
Verified by: National Institute on Alcohol Abuse and Alcoholism (NIAAA), April 2008
Clinical Trial Phase: N/A | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 80
Brief Summary
Official Title: “Human CYP2B6: Induction by Ethanol and Polymorphisms”
Condition Keyword(s):
Intervention(s):
The two purposes of this study are
1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has
1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
2. on the stimulant effect of bupropion and
2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has
1. on the blood levels of bupropion and its major breakdown products in the blood and
2. on the stimulant effect of bupropion.
Two groups of volunteers will be recruited for this study:
1. volunteers who drink moderate to heavy amounts of alcohol frequently and
2. volunteers who usually do not drink alcohol.
Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Study Primary Completion Date: April 2008
Intervention(s) in this Clinical Trial
- Drug: Bupropion
- Drug: Chlorzoxazone
- Drug: Ethanol
Outcome Measures for this Clinical Trial
Primary Measures
- Agitation
- Insomnia
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy adults who are 21 - 55 years of age.
- Either 1) Moderate-to-heavy drinkers who drink on average more than 14 but less than 28 drinks per week; OR 2) adults who normally abstain from drinking alcohol.
Exclusion Criteria:
- Participants who are currently taking prescription medications (including oral contraceptives)
- Pregnancy
- Body mass index (BMI) greater than 30
- History of seizures or eating disorders
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Overall Clinical Trial Officials and Contacts
David J. Greenblatt, MD Principal Investigator Tufts University; Chair of Department of Pharmacology and Experimental Therapeutics, Sackler School
Related Publications
References
Hesse LM, Venkatakrishnan K, Court MH, von Moltke LL, Duan SX, Shader RI, Greenblatt DJ. CYP2B6 mediates the in vitro hydroxylation of bupropion: potential drug interactions with other antidepressants. Drug Metab Dispos. 2000 Oct;28(10):1176-83.
Hesse LM, He P, Krishnaswamy S, Hao Q, Hogan K, von Moltke LL, Greenblatt DJ, Court MH. Pharmacogenetic determinants of interindividual variability in bupropion hydroxylation by cytochrome P450 2B6 in human liver microsomes. Pharmacogenetics. 2004 Apr;14(4):225-38. Erratum in: Pharmacogenetics. 2005 Apr;15(4):265.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00330434
Study ID Number: NIAAAGRE15647
ClinicalTrials.gov Identifier: NCT00330434
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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