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Completed

NCT Number: NCT00256451

Endophenotype for Alcohol Misuse in Healthy Minority Populations

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.

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Key information

Conditions

Healthy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone

Drug

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

Other names: ReVia

Placebo

Drug

placebo pills

Alcohol

Other

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

Sham alcohol

Other

non-alcoholic placebo alcohol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations

Acronym: DEFINE

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2005
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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