Endophenotype for Alcohol Misuse in Healthy Minority Populations

NCT00256451 | Completed Phase 4 Results

• 1 other identifier: 803866
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Naltrexone; Alcohol

Outcome Measures

Primary Outcomes (3)

• Biphasic Alcohol Effects Scale - Stimulation

  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.

  During challenge sessions

• Profile of Mood States - Vigor

  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

  during the challenge session

• Subjective High From Alcohol Scale

  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

  during the alcohol ingestion

Secondary Outcomes (2)

• Biphasic Alcohol Effects Scale - Sedation

  During the challenge session

• Profile of Mood States - Fatigue Scale

  During the challenge session

Study Arms (4)

ALC and NAL

EXPERIMENTAL

alcohol and active naltrexone

Drug: Naltrexone; Other: alcohol

Sham ALC and NAL

ACTIVE COMPARATOR

"sham" alcohol and active naltrexone

Drug: Naltrexone; Other: Sham alcohol

placebo pill and ALC

PLACEBO COMPARATOR

placebo naltrexone and alcohol

Drug: placebo; Other: alcohol

placebo pill and Sham ALC

PLACEBO COMPARATOR

placebo naltrexone and placebo (non-alcoholic) alcohol

Drug: placebo; Other: Sham alcohol

Interventions

Naltrexone DRUG

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

Also known as: ReVia

ALC and NAL; Sham ALC and NAL

placebo DRUG

placebo pills

placebo pill and ALC; placebo pill and Sham ALC

alcohol OTHER

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

ALC and NAL; placebo pill and ALC

Sham alcohol OTHER

non-alcoholic placebo alcohol

Sham ALC and NAL; placebo pill and Sham ALC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Naltrexone; Ethanol; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Alcohols; Organic Chemicals

Results Point of Contact

• Title: David Oslin, MD
• Organization: University of Pennsylvania

oslin@upenn.edu

2158235894

Study Officials

• David Oslin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: November 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 21, 2019
• Results First Posted: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)