Behavioral Therapy Plus Naltrexone for Alcoholism

Alcoholism Clinical Trial

Official title:

Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000456
• Other study ID #: NIAAAANT09568
• Secondary ID: R01AA009568
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: October 1, 2010
• Start date: September 1992
• Est. completion date: August 2002

Study information

• Verified date: October 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Behavioral:
• cognitive behavior therapy

• motivational enhancement therapy

Locations

Country	Name	City	State
United States	Medical Univ. of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Anton RF, Moak DH, Latham P, Waid LR, Myrick H, Voronin K, Thevos A, Wang W, Woolson R. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005 Aug;25(4):349-57. — View Citation