Behavioral Therapy Plus Naltrexone for Alcoholism

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00000456
First received: November 2, 1999
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.


Condition Intervention Phase
Alcoholism
Alcohol Dependence
Drug: naltrexone (Revia)
Behavioral: cognitive behavior therapy
Behavioral: motivational enhancement therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Enrollment: 160
Study Start Date: September 1992
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification.
  • Consumes on average five standard drinks per day.
  • Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements.
  • Able to read and understand questionnaires and informed consent.
  • Lives within 50 miles of the study site.

Exclusion Criteria:

  • Currently meets criteria for any other psychoactive substance dependency disorder.
  • Ever abused opiates.
  • Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen.
  • Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
  • Meets criteria for dissociate disorder or eating disorders.
  • Has current suicidal or homicidal ideation.
  • Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
  • Current use of disulfiram (Antabuse).
  • Clinically significant medical problems that would impair participation or limit medication ingestion.
  • Hepatocellular disease.
  • Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
  • Have current charges pending for a violent crime.
  • Does not have a stable living situation and a reliable source of collateral reporting.
  • Has taken an opiate antagonist drug in the last month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000456

Locations
United States, South Carolina
Medical Univ. of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Ray Anton, MD Medical University of South Carolina
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000456     History of Changes
Other Study ID Numbers: NIAAAANT09568, R01AA009568
Study First Received: November 2, 1999
Last Updated: October 1, 2010
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
Alcoholism
Alcohol Dependence
Naltrexone
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014