Behavioral Therapy Plus Naltrexone for Alcoholism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-09-30

Study Completion Date

2002-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholism Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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naltrexone (Revia)

Intervention Type DRUG

cognitive behavior therapy

Intervention Type BEHAVIORAL

motivational enhancement therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ray Anton, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical Univ. of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/01.jcp.0000172071.81258.04.

Reference Type RESULT

PMID: 16012278 (View on PubMed)

Other Identifiers

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R01AA009568

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAANT09568

Identifier Type: -

Identifier Source: org_study_id