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Behavioral Therapy Plus Naltrexone for Alcoholism

This study has been completed.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Medical University of South Carolina Identifier:
First received: November 2, 1999
Last updated: October 1, 2010
Last verified: October 2010
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
Alcohol Dependence
Drug: naltrexone (Revia)
Behavioral: cognitive behavior therapy
Behavioral: motivational enhancement therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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)

Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00000456

United States, South Carolina
Medical Univ. of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Ray Anton, MD Medical University of South Carolina
  More Information

Publications: Identifier: NCT00000456     History of Changes
Other Study ID Numbers: NIAAAANT09568
R01AA009568 ( US NIH Grant/Contract Award Number )
Study First Received: November 2, 1999
Last Updated: October 1, 2010

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

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 28, 2017