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OpenTrials
Completed

NCT Number: NCT00000442

Naltrexone for Relapse Prevention

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

naltrexone (Revia)

Drug

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Etiology and Treatment of Alcohol Dependence

Important dates

Study completion
2002
First posted
Nov 3, 1999
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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