Naltrexone Treatment for Alcoholism

Alcoholism Clinical Trial

Official title:

Naltrexone Treatment for Alcoholism: Predicting Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000438
• Other study ID #: NIAAAMCC11855
• Secondary ID: R01AA011855
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: May 13, 2010
• Est. completion date: March 2003

Study information

• Verified date: May 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

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

Country where clinical trial is conducted

United States,