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Endophenotype for Alcohol Misuse in Healthy Minority Populations

NCT00256451 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-08-21

Study results available
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Summary

The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.

Conditions

  • Healthy

Interventions

DRUG

Naltrexone

50 mg/day for two days prior to the alcohol challenge session

DRUG

placebo

placebo pills

OTHER

alcohol

190 proof alcohol prepared to 11% volume mixed with fruit juice.

OTHER

Sham alcohol

non-alcoholic placebo alcohol

Sponsors & Collaborators

Principal Investigators

  • David Oslin, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00256451 on ClinicalTrials.gov