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Clinical Trial: Naltrexone Treatment for Alcoholism
This study has been completed.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism | Drug: naltrexone (Revia) | Phase IV |
MedlinePlus related topics: Alcoholism
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Efficacy Study
Official Title: Naltrexone Treatment for Alcoholism: Predicting Outcome
Expected Total Enrollment: 192
Study completion: March 2003
Eligibility
Ages Eligible for Study: 30 Years - 55 Years, Genders Eligible for Study: Both
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.
Location Information
Maryland
Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States
More Information
Record last reviewed: November 2004
Last Updated: November 22, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000438
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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