Conditions: Healthy
Keywords: Naltrexone Alcohol
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 43
Healthy volunteers: yes

Brief 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.

Detailed description:
We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.

Arms:
arm 1: alcohol and active naltrexone arm 2: "sham" alcohol and active naltrexone arm 3: placebo naltrexone and alcohol arm 4: placebo naltrexone and placebo (non-alcoholic) alcohol

Interventions: intervention 1: Naltrexone intervention 2: placebo intervention 3: alcohol intervention 4: Sham alcohol
Intervention descriptions: intervention 1: 50 mg/day for two days prior to the alcohol challenge session intervention 2: placebo pills intervention 3: 190 proof alcohol prepared to 11% volume mixed with fruit juice. intervention 4: non-alcoholic placebo alcohol

Protocol document: