Naltrexone for Relapse Prevention

Completed · Phase 4

Conditions studied: Alcoholism

In brief

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.

Key facts

Study ID

NCT00000442

Run by

UConn Health

People needed

57

Expected to finish

2002-12-01

Last updated by the study team

2011-06-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Psychiatry, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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