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CompletedNCT00000442Updated Jun 20, 2011

Naltrexone for Relapse Prevention

A Phase 4 interventional study of naltrexone (Revia) in Alcoholism, sponsored by UConn Health. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-06-20.

Sponsored by UConn Health · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
57
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Alcoholism

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In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 57 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

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Lead sponsor

UConn Health is the lead sponsor of 182 studies on the registry; 18 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
57 participants

Interventions

  • Drugnaltrexone (Revia)
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Study locations

1 site
  • Department of Psychiatry, University of Pennsylvania
    Philadelphia, Pennsylvania 19103, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000442
Lead sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted
Nov 3, 1999
Completion
Dec 2002
Last update
Jun 20, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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