Endophenotype for Alcohol Misuse in Healthy Minority Populations

Completed · Phase 4 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00256451

Run by

University of Pennsylvania

People needed

43

Starts

2005-11-01

Expected to finish

2008-05-01

Last updated by the study team

2019-08-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female and 21 years of age or older
• Drinks less than an average of 21 drinks/week with no more than 2 binge episodes per week
• Of African descent by self report

You may not qualify if…

• Meets DSM-IV criteria for lifetime dependence on any substance other than nicotine
• Subjects who test positive on the urine drug screen for opioids, cocaine, marijuana, or amphetamine at the screening visit
• Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
• The presence of unstable or serious medical illness; including history of stroke, seizure disorder, severe liver disease (AST or ALT > 5X normal at the time of randomization), or unstable cardiac disease
• Needs treatment with any psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication)
• Pre-menopausal female subjects who are pregnant, nursing, or not using a reliable method of contraception
• Insulin-dependent diabetes
• Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI.

Where it is running

• University of Pennsylvania Treatment Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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