Alcoholism
Conditions
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.
Interventions
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed