Naltrexone for Relapse Prevention

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UConn Health
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone

Criteria

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.