Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Sponsor

Tufts University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00330434

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The two purposes of this study are

to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has
on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
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
on the blood levels of bupropion and its major breakdown products in the blood and
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 or Disease	Intervention/Treatment	Phase
Alcohol Drinking Depression Smoking Cessation Attention Deficit Disorder	Other: Trial Withdrawn 1 Other: Trial Withdrawn 2	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Human CYP2B6: Induction by Ethanol and Polymorphisms

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: Trial Withdrawn 2 Trial Withdrawn 2	Other: Trial Withdrawn 2 Trial Withdrawn 2
Other: Trial Withdrawn 1 Trial Withdrawn 1	Other: Trial Withdrawn 1 Trial Withdrawn 1

Arm

Intervention/Treatment

Other: Trial Withdrawn 2

Trial Withdrawn 2

Other: Trial Withdrawn 2

Trial Withdrawn 2

Other: Trial Withdrawn 1

Trial Withdrawn 1

Other: Trial Withdrawn 1

Trial Withdrawn 1

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Tufts University School of Medicine	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

Tufts University
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