Naltrexone Treatment for Alcoholism
Completed · Phase 4
Conditions studied: Alcoholism
In brief
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.
Key facts
- Study ID
- NCT00000438
- Run by
- Johns Hopkins University
- People needed
- 192
- Expected to finish
- 2003-03-01
- Last updated by the study team
- 2010-05-14
Who can join
Age: 30 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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