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Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00330434
First Posted: May 26, 2006
Last Update Posted: April 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330434


Locations
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Sponsors and 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00330434     History of Changes
Other Study ID Numbers: NIAAAGRE15647
1F32AA015647-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2006
First Posted: May 26, 2006
Last Update Posted: April 9, 2008
Last Verified: April 2008

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
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Depression
Alcohol Drinking
Behavioral Symptoms
Drinking Behavior
Bupropion
Ethanol
Chlorzoxazone
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents