Naltrexone for Relapse Prevention

Alcoholism Clinical Trial

Official title:

Etiology and Treatment of Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000442
• Other study ID #: NIAAAKRA3510
• Secondary ID: P50AA003510
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 17, 2011
• Est. completion date: December 2002

Study information

• Verified date: June 2011
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Meets criteria for alcohol dependence.

• Abstinent from alcohol for a period of at least 3 days prior to beginning of study.

• Able to read English and complete study evaluations.

• Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.

Exclusion Criteria:

• Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.

• Prior history of opioid dependence.

• Regular use of psychoactive drugs including anxiolytics and antidepressants.

• Prior treatment with naltrexone.

• Current use of disulfiram.

• Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).

• Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.

• Abstinent longer than 28 days prior to randomization.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Locations

Country	Name	City	State
United States	Department of Psychiatry, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,