Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Not Applicable

Withdrawn

• Conditions: Depression; Smoking Cessation; Attention Deficit Disorder; Alcohol Drinking
• Interventions: Other: Trial Withdrawn 1; Other: Trial Withdrawn 2

• Registration Number: NCT00330434
• Lead Sponsor: Tufts University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-25
• Study First Posted: 2006-05-26
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial Withdrawn 1	Trial Withdrawn 1	Trial Withdrawn 1
Trial Withdrawn 2	Trial Withdrawn 2	Trial Withdrawn 2

Trial Locations

Locations (1)

Tufts University School of Medicine; 🇺🇸 Boston, Massachusetts, United States