Endophenotype for Alcohol Misuse in Healthy Minority Populations (DEFINE)

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00256451
First received: November 17, 2005
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.


Condition Intervention Phase
Healthy
Drug: Naltrexone
Drug: placebo
Other: alcohol
Other: placebo alcohol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Physiological and subjective response [ Time Frame: During challenge sessions ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALC and NAL
alcohol and active naltrexone
Drug: Naltrexone
50 mg/day for two days prior to the alcohol challenge session
Other Name: ReVia
Other: alcohol
190 proof alcohol prepared to 11% volume mixed with fruit juice.
Active Comparator: placebo ALC and NAL
"sham" alcohol and active naltrexone
Drug: Naltrexone
50 mg/day for two days prior to the alcohol challenge session
Other Name: ReVia
Other: placebo alcohol
non-alcoholic placebo alcohol
Placebo Comparator: placebo pill and ALC
placebo naltrexone and alcohol
Drug: placebo
placebo pills
Other: alcohol
190 proof alcohol prepared to 11% volume mixed with fruit juice.
Placebo Comparator: placebo pill and placebo ALC
placebo naltrexone and placebo (non-alcoholic) alcohol
Drug: placebo
placebo pills
Other: placebo alcohol
non-alcoholic placebo alcohol

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256451

Locations
United States, Pennsylvania
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: David Oslin, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: David Oslin, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00256451     History of Changes
Other Study ID Numbers: 803866
Study First Received: November 17, 2005
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Naltrexone
Endophenotype

Additional relevant MeSH terms:
Ethanol
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014