CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Naltrexone +3 moredrug
Likely dose
Naltrexone 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00256451
NCT00256451Phase 4Completed

Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations

University of Pennsylvania·interventional·Posted Nov 21, 2005·Updated Aug 21, 2019

In Brief

A Phase 4 clinical trial evaluating Naltrexone, placebo, and 2 other interventions for Healthy. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 21, 2005
Enrollment StartNov 1, 2005
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.6 years ago

Interventions

Naltrexonedrug

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

placebodrug

placebo pills

alcoholother

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

Sham alcoholother

non-alcoholic placebo alcohol