Naltrexone for Relapse Prevention

UConn Health

Status and phase: Completed; Phase 4

Conditions: Alcoholism

Treatments: Drug: naltrexone (Revia)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000442

NIAAAKRA3510

P50AA003510 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.