Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations
Overview
- Phase
- Phase 4
- Intervention
- Sham alcohol
- Conditions
- Healthy
- Sponsor
- University of Pennsylvania
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Profile of Mood States - Vigor
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
David Oslin
Principal Investigator
University of Pennsylvania
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.
Arms & Interventions
Sham ALC and NAL
"sham" alcohol and active naltrexone
Intervention: Sham alcohol
ALC and NAL
alcohol and active naltrexone
Intervention: Naltrexone
ALC and NAL
alcohol and active naltrexone
Intervention: alcohol
Sham ALC and NAL
"sham" alcohol and active naltrexone
Intervention: Naltrexone
placebo pill and ALC
placebo naltrexone and alcohol
Intervention: placebo
placebo pill and ALC
placebo naltrexone and alcohol
Intervention: alcohol
placebo pill and Sham ALC
placebo naltrexone and placebo (non-alcoholic) alcohol
Intervention: placebo
placebo pill and Sham ALC
placebo naltrexone and placebo (non-alcoholic) alcohol
Intervention: Sham alcohol
Outcomes
Primary Outcomes
Profile of Mood States - Vigor
Time Frame: during the challenge session
Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion Profile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome
Biphasic Alcohol Effects Scale - Stimulation
Time Frame: During challenge sessions
Change from baseline to peak for the feeling of stimulation after alcohol ingestion Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.
Subjective High From Alcohol Scale
Time Frame: during the alcohol ingestion
Change from baseline to peak for the self reported feeling of being high after drinking Subjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes
Secondary Outcomes
- Profile of Mood States - Fatigue Scale(During the challenge session)
- Biphasic Alcohol Effects Scale - Sedation(During the challenge session)