Naltrexone for Relapse Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000442
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 20, 2011
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
UConn Health

Brief 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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: naltrexone (Revia) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Etiology and Treatment of Alcohol Dependence
Estimated Study Completion Date : December 2002

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000442

United States, Pennsylvania
Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Responsible Party: Henry Kranzler, University of Pennsylvania Identifier: NCT00000442     History of Changes
Other Study ID Numbers: NIAAAKRA3510
P50AA003510 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents