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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1
Medical Univ. of South Carolina
Charleston, South Carolina, United States, 29425