Naltrexone Treatment for Alcoholism: Predicting Outcome

Johns Hopkins University1 site in 1 country192 target enrollmentNovember 3, 1999

ConditionsAlcoholism

Drugsnaltrexone (Revia)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Alcoholism
Sponsor: Johns Hopkins University
Enrollment: 192
Locations: 1
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.

Registry

clinicaltrials.gov

Start Date

November 3, 1999

End Date

March 2003

Last Updated

15 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

•Meets criteria for alcohol dependence.
•Committed to alcohol abstinence as a treatment goal.
•Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.

Exclusion Criteria

•Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
•Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
•Females who are pregnant, lactating, or not using a reliable method of contraception.
•Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
•Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
•Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
•Vocabulary below the 5th grade reading level.
•Abnormal MRI scan.
•HIV infection due to the neurological sequelae.
•Significant central nervous system diseases.