Endophenotype for Alcohol Misuse in Healthy Minority Populations (DEFINE)

• 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: University of Pennsylvania
• Information provided by (Responsible Party): David Oslin, University of Pennsylvania

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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

• Responsible Party: David Oslin, Principal Investigator, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00256451
• Other Study ID Numbers: 803866
• First Posted: November 21, 2005
• 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:

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