Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism - Full Text View

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00330434

Purpose

The two purposes of this study are

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
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:

volunteers who drink moderate to heavy amounts of alcohol frequently and
volunteers who usually do not drink alcohol.

Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.

Condition	Intervention
Alcohol Drinking Depression Smoking Cessation Attention Deficit Disorder	Drug: Bupropion Drug: Chlorzoxazone Drug: Ethanol

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Human CYP2B6: Induction by Ethanol and Polymorphisms

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Attention Deficit Hyperactivity Disorder Depression Quitting Smoking Smoking

Drug Information available for: Ethanol Bupropion hydrochloride Bupropion Chlorzoxazone

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Agitation
Insomnia

Estimated Enrollment:	80
Study Start Date:	December 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330434

Locations

United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:	David J. Greenblatt, MD	Tufts University; Chair of Department of Pharmacology and Experimental Therapeutics, Sackler School
Principal Investigator:	Michael H. Court, BVsc, PhD	Tufts University, Department of Pharmacology and Experimental Therapeutics, Sackler School

More Information

Publications:

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.

Study ID Numbers:	NIAAAGRE15647, 1 F32 AA15647-01A1
Study First Received:	May 25, 2006
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00330434 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Alcohol
Bupropion
Chlorzoxazone
Interaction
Induction
Depression
Smoking
Drinking

Cytochrome P450 Enzyme
CYP2B6
CYP2E1
Pharmacogenetics
Pharmacokinetics
Pharmacodynamics
Boston
Tufts University

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Anti-Infective Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Neuromuscular Agents
Habits
Smoking
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Muscle Relaxants, Central
Mental Disorders Diagnosed in Childhood

Antidepressive Agents, Second-Generation
Antidepressive Agents
Ethanol
Depression
Chlorzoxazone
Drinking Behavior
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Depressants
Depressive Disorder
Alcohol Drinking
Pharmacologic Actions
Behavioral Symptoms
Anti-Infective Agents, Local
Bupropion
Mood Disorders

ClinicalTrials.gov processed this record on November 09, 2009