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Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00330434
First received: May 25, 2006
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Human CYP2B6: Induction by Ethanol and Polymorphisms

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
ClinicalTrials.gov Identifier: NCT00330434     History of Changes
Other Study ID Numbers: NIAAAGRE15647, 1 F32 AA15647-01A1
Study First Received: May 25, 2006
Last Updated: April 7, 2008
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:
Attention Deficit Disorder with Hyperactivity
Depressive Disorder
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders
Alcohol Drinking
Depression
Behavioral Symptoms
Drinking Behavior
Bupropion
Chlorzoxazone
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on November 27, 2014