Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism - Tabular View

Tracking Information

First Received Date ^ICMJE

May 25, 2006

Last Updated Date

April 7, 2008

Start Date ^ICMJE

December 2005

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Agitation
Insomnia

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00330434 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Official Title ^ICMJE

Human CYP2B6: Induction by Ethanol and Polymorphisms

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Alcohol Drinking
Depression
Smoking Cessation
Attention Deficit Disorder

Intervention ^ICMJE

Drug: Bupropion
Drug: Chlorzoxazone
Drug: Ethanol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00330434

Responsible Party

Study ID Numbers ^ICMJE

NIAAAGRE15647, 1 F32 AA15647-01A1

Study Sponsor ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP