Status:

COMPLETED

Behavioral Therapy Plus Naltrexone for Alcoholism

Lead Sponsor:

Medical University of South Carolina

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcoholism

Alcohol Dependence

Eligibility:

All Genders

21-70 years

Phase:

PHASE4

Brief 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,...

Eligibility 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.

Key Trial Info

Start Date :

September 1 1992

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2002

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT00000456

Start Date

September 1 1992

End Date

August 1 2002

Last Update

October 4 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Medical Univ. of South Carolina

Charleston, South Carolina, United States, 29425

Behavioral Therapy Plus Naltrexone for Alcoholism | DecenTrialz