Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Depression Clinical Trial

Official title:

Human CYP2B6: Induction by Ethanol and Polymorphisms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00330434
• Other study ID #: NIAAAGRE15647
• Secondary ID: F32AA015647-01A1
• Status: Withdrawn
• Phase: N/A
• Start date: December 2005
• Est. completion date: April 2008

Study information

• Verified date: November 2020
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Depression
• Smoking Cessation

Intervention

Other:
• Trial Withdrawn 1
Trial Withdrawn 1
• Trial Withdrawn 2
Trial Withdrawn 2

Locations

Country	Name	City	State
United States	Tufts University School of Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hesse LM, He P, Krishnaswamy S, Hao Q, Hogan K, von Moltke LL, Greenblatt DJ, Court MH. Pharmacogenetic determinants of interindividual variability in bupropion hydroxylation by cytochrome P450 2B6 in human liver microsomes. Pharmacogenetics. 2004 Apr;14(4):225-38. Erratum in: Pharmacogenetics. 2005 Apr;15(4):265. — View Citation

Hesse LM, Venkatakrishnan K, Court MH, von Moltke LL, Duan SX, Shader RI, Greenblatt DJ. CYP2B6 mediates the in vitro hydroxylation of bupropion: potential drug interactions with other antidepressants. Drug Metab Dispos. 2000 Oct;28(10):1176-83. — View Citation