Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism
NCT ID: NCT00330434
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2005-12-31
2008-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trial Withdrawn 2
Trial Withdrawn 2
Trial Withdrawn 2
Trial Withdrawn 2
Trial Withdrawn 1
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Trial Withdrawn 1
Trial Withdrawn 1
Interventions
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Trial Withdrawn 1
Trial Withdrawn 1
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Trial Withdrawn 2
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Body mass index (BMI) greater than 30
* History of seizures or eating disorders
21 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Tufts University
OTHER
Responsible Party
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Principal Investigators
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David J. Greenblatt, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts University; Chair of Department of Pharmacology and Experimental Therapeutics, Sackler School
Michael H. Court, BVsc, PhD
Role: PRINCIPAL_INVESTIGATOR
Tufts University, Department of Pharmacology and Experimental Therapeutics, Sackler School
Locations
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Tufts University School of Medicine
Boston, Massachusetts, United States
Countries
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References
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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. doi: 10.1097/00008571-200404000-00002.
Other Identifiers
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