Naltrexone Treatment for Alcoholism

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone

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.

• Seizure disorder or history of closed head trauma.

• Neuroendocrine disorders.

• Treatment with opiates within the last six months.