Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

November 6, 2020 updated by: Tufts University

Human CYP2B6: Induction by Ethanol and Polymorphisms

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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Other: Trial Withdrawn 2
Other: Trial Withdrawn 2
Trial Withdrawn 2
Other: Trial Withdrawn 1
Other: Trial Withdrawn 1
Trial Withdrawn 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 25, 2006

First Submitted That Met QC Criteria

May 25, 2006

First Posted (Estimate)

May 26, 2006

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAGRE15647
  • F32AA015647-01A1 (U.S. NIH Grant/Contract)
  • 1F32AA015647-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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