Naltrexone Treatment for Alcoholism

Phase 4

Completed

• Conditions: Alcoholism

• Registration Number: NCT00000438
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Study Completion: 2003-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-13
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.
• Seizure disorder or history of closed head trauma.
• Neuroendocrine disorders.
• Treatment with opiates within the last six months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States