Behavior and Naltrexone Treatment for Alcoholics

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 Completion Date

2000-03-31

Brief Summary

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The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.

Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Interventions

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naltrexone (Revia)

Intervention Type DRUG

cognitive behavioral therapy

Intervention Type BEHAVIORAL

cue exposure treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for alcohol dependence.

Exclusion Criteria

* Current diagnosis of dependence on other substances except nicotine.
* A history of psychosis or current psychotic symptoms.
* Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
* Current use of disulfiram (Antabuse).
* Evidence of significant cerebral, renal, thyroid, or cardiac disease.
* History of opioid abuse in the previous year.
* History of cirrhosis, hepatocellular disease, or elevated bilirubin.
* Females who are pregnant, nursing, or not using a reliable method of birth control.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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NIAAAMON7850

Identifier Type: -

Identifier Source: org_study_id