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Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Human CYP2B6: Induction by Ethanol and Polymorphisms

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00330434
Enrollment
0
Registered
2006-05-26
Start date
2005-12-31
Completion date
2008-04-30
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Attention Deficit Disorder, Depression, Smoking Cessation

Keywords

Alcohol, Bupropion, Chlorzoxazone, Interaction, Induction, Depression, Smoking, Drinking, Cytochrome P450 Enzyme, CYP2B6, CYP2E1, Pharmacogenetics, Pharmacokinetics, Pharmacodynamics, Boston, 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.

Interventions

OTHERTrial Withdrawn 1

Trial Withdrawn 1

OTHERTrial Withdrawn 2

Trial Withdrawn 2

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Tufts University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026