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Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Primary Purpose

Alcohol Drinking, Depression, Smoking Cessation

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trial Withdrawn 1

Trial Withdrawn 2

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring Alcohol, Bupropion, Chlorzoxazone, Interaction, Induction, Depression, Smoking, Drinking, Cytochrome P450 Enzyme, CYP2B6, CYP2E1, Pharmacogenetics, Pharmacokinetics, Pharmacodynamics, Boston, Tufts University

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Tufts University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Trial Withdrawn 2

Trial Withdrawn 1

Arm Description

Trial Withdrawn 2

Trial Withdrawn 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00330434

First Posted

May 25, 2006

Last Updated

November 6, 2020

Sponsor

Tufts University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00330434

Brief Title

Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Official Title

Human CYP2B6: Induction by Ethanol and Polymorphisms

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Study was a F32 Fellowship. Trial was proposed however Principle Investigator does not believe trial took place.

Study Start Date

December 2005 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The two purposes of this study are to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and on the stimulant effect of bupropion and to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has on the blood levels of bupropion and its major breakdown products in the blood and on the stimulant effect of bupropion. Two groups of volunteers will be recruited for this study: volunteers who drink moderate to heavy amounts of alcohol frequently and volunteers who usually do not drink alcohol. Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking, Depression, Smoking Cessation, Attention Deficit Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trial Withdrawn 2

Arm Type

Other

Arm Description

Trial Withdrawn 2

Arm Title

Trial Withdrawn 1

Arm Type

Other

Arm Description

Trial Withdrawn 1

Intervention Type

Other

Intervention Name(s)

Trial Withdrawn 1

Intervention Description

Trial Withdrawn 1

Intervention Type

Other

Intervention Name(s)

Trial Withdrawn 2

Intervention Description

Trial Withdrawn 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David J. Greenblatt, MD

Organizational Affiliation

Tufts University; Chair of Department of Pharmacology and Experimental Therapeutics, Sackler School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael H. Court, BVsc, PhD

Organizational Affiliation

Tufts University, Department of Pharmacology and Experimental Therapeutics, Sackler School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts University School of Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10997936

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.

Results Reference

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PubMed Identifier

15083067

Citation

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. doi: 10.1097/00008571-200404000-00002. Erratum In: Pharmacogenetics. 2005 Apr;15(4):265.

Results Reference

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Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

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