Naltrexone Treatment for Alcoholism

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Alcoholism

Treatments: Drug: naltrexone (Revia)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000438

NIAAAMCC11855

R01AA011855 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

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.