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Endophenotype for Alcohol Misuse in Healthy Minority Populations (DEFINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00256451
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
David Oslin, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Naltrexone Drug: placebo Other: alcohol Other: Sham alcohol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations
Study Start Date : November 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: Sham 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: Sham 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 Sham ALC
placebo naltrexone and placebo (non-alcoholic) alcohol
Drug: placebo
placebo pills

Other: Sham alcohol
non-alcoholic placebo alcohol




Primary Outcome Measures :
  1. 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.


  2. 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


  3. 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 Outcome Measures :
  1. Biphasic Alcohol Effects Scale - Sedation [ Time Frame: During the challenge session ]

    Change from baseline to peak of the amount of sedation post ingestion of alcohol

    Biphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes


  2. Profile of Mood States - Fatigue Scale [ Time Frame: During the challenge session ]

    Change from baseline to peak of the degree of fatigue experienced after alcohol ingestion

    Profile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256451


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

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Responsible Party: David Oslin, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00256451    
Other Study ID Numbers: 803866
First Posted: November 21, 2005    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Oslin, University of Pennsylvania:
Naltrexone
Alcohol
Additional relevant MeSH terms:
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Ethanol
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Alcohol Deterrents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents