Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

naltrexone (Revia)

+ cognitive behavior therapy

+ motivational enhancement therapy

DrugBehavioral
Who is being recruted

Mental Disorders+2

+ Substance-Related Disorders

+ Alcohol-Related Disorders

From 21 to 70 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 1992
See protocol details

Summary

Principal SponsorMedical University of South Carolina
Last updated: October 4, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00000456
Principal SponsorMedical University of South Carolina
Last updated: October 4, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholism

Criteria

5 inclusion criteria required to participate
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
Consumes on average five standard drinks per day
Lives within 50 miles of the study site
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14 exclusion criteria prevent from participating
Clinically significant medical problems that would impair participation or limit medication ingestion
Current use of disulfiram (Antabuse)
Currently meets criteria for any other psychoactive substance dependency disorder
Does not have a stable living situation and a reliable source of collateral reporting
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical Univ. of South Carolina

Charleston, United StatesOpen Medical Univ. of South Carolina in Google Maps
CompletedOne Study Center