Endophenotype for Alcohol Misuse in Healthy Minority Populations

NCT ID: NCT00256451

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-05-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

ALC and NAL

alcohol and active naltrexone

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

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

alcohol

Intervention Type: OTHER

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

Sham ALC and NAL

"sham" alcohol and active naltrexone

Group Type: ACTIVE_COMPARATOR

Naltrexone

Intervention Type: DRUG

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

Sham alcohol

Intervention Type: OTHER

non-alcoholic placebo alcohol

placebo pill and ALC

placebo naltrexone and alcohol

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo pills

alcohol

Intervention Type: OTHER

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

placebo pill and Sham ALC

placebo naltrexone and placebo (non-alcoholic) alcohol

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo pills

Sham alcohol

Intervention Type: OTHER

non-alcoholic placebo alcohol

Interventions

Naltrexone

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

Intervention Type: DRUG

placebo

placebo pills

Intervention Type: DRUG

alcohol

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

Intervention Type: OTHER

Sham alcohol

non-alcoholic placebo alcohol

Intervention Type: OTHER

Other Intervention Names

ReVia

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

David Oslin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Oslin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

803866

Identifier Type: -

Identifier Source: org_study_id