Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.

NCT00366626 | Completed Phase 4 Results DMC

• 1 other identifier: P50AA010761
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) is more effective in the reduction of alcohol craving and drinking compared to placebo in individuals with particular genetic predisposition.

Conditions

Alcohol Dependence

Keywords

Alcohol dependence; Alcoholism; Craving; Genetic

Outcome Measures

Primary Outcomes (2)

• "Natural" Alcohol Consumption Period; Average Number of Drinks Per Day Consumed During the 5 Day Natural (Usual Environment) Drinking Observation Period

  treatment days 1 - 5

• Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed

  Subjects were allowed to drink up to 8 alcohol drinks during 2 hours observation period being in bar/laboratory settings vs to get $2 per each not consumed drink.

  On day 7 of treatment during limited access alcohol consuption in the bar/laboratory

Study Arms (2)

1.

EXPERIMENTAL

Naltrexone one capsule a day

Drug: Naltrexone

2

PLACEBO COMPARATOR

One capsule a day match to naltrexone

Drug: Placebo

Interventions

Naltrexone DRUG

Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7)

Also known as: ReVia

1.

Placebo DRUG

Placebo for 7 days matched to Naltrexone

2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 21-65. 2. Meets the DSM IV criterion for current alcohol dependence including "loss of control over drinking" (criterion 4) but does not necessarily have signs of physiologic dependence as expressed in criterion for tolerance development (criterion 1) and withdrawal symptoms or use to avoid withdrawal symptoms (criterion 2).
• \. Drinks hard liquor/spirits and does not have aversion to this form of alcohol.
• \. Drinks alone (not in the presence of others) some of the time (to maximize the potential of drinking in the bar lab where a subject will not be in the company of others).
• \. Currently is not engaged in, and does not want treatment for, alcohol related problems.
• \. Able to read and understand questionnaires and informed consent. 7. Lives within 50 miles of the study site. 8. Able to maintain abstinence for two days (without the aid of detox medications) as determined by self-report and breathalyzer measurements.
• Does not have metal objects in the head/neck.
• Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

You may not qualify if:

• \. Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder.
• \. History of opiate abuse or a positive urine drug screen for opiates. 3. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days as evidenced by self-report and urine drug screen. For marijuana - no use within the last seven days.
• \. Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders and eating disorders, any other psychotic disorder or an organic mental disorder.
• \. Has current suicidal ideation or homicidal ideation. 6. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.
• \. Current use of disulfiram, naltrexone, or acamprosate. 8. Clinically significant medical problems such as, cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
• \. Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
• \. Hepatocellular disease indicated by elevations of SGPT Alanine transaminase(ALT) or SGOT Aspartate transaminase(AST) greater than 3 times normal at screening.
• \. Females of child-bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
• \. Has current charges pending for a violent crime (not including DUI related offenses).
• \. Does not have a stable living situation.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

· Center for Drug and Alcohol Programs,· Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Anton RF, Voronin KK, Randall PK, Myrick H, Tiffany A. Naltrexone modification of drinking effects in a subacute treatment and bar-lab paradigm: influence of OPRM1 and dopamine transporter (SLC6A3) genes. Alcohol Clin Exp Res. 2012 Nov;36(11):2000-7. doi: 10.1111/j.1530-0277.2012.01807.x. Epub 2012 May 2.

  PMID: 22551036 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

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

Results Point of Contact

• Title: Dr. Raymond F. Anton, Distinguished University Professor
• Organization: Medical University of South Carolina

antonr@musc.edu

843-792-1226

Study Officials

• Raymond F Anton, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 5, 2017
• Results First Posted: December 3, 2012

Record last verified: 2012-11

Locations

US (1)