Status:

COMPLETED

Naltrexone Maintenance Treatment of Alcoholism

Lead Sponsor:

The Scripps Research Institute

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcoholism

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatme...

Eligibility Criteria

Inclusion Criteria:

  • Meets criteria for alcohol dependence.
  • Expresses a desire to cut down or stop drinking.

Exclusion Criteria:

  • Currently meets criteria for dependence on substances other than alcohol.
  • History of opiate dependence or evidence of current opiate use.
  • Significant medical disorders that will increase potential risk or interfere with study participation.
  • Liver function tests more than 3 times normal or elevated bilirubin.
  • Female patients who are pregnant, nursing, or not using a reliable method of birth control.
  • Inability to understand and provide a consent form.
  • Treatment with an investigational drug during the previous month.
  • Prior treatment with naltrexone.
  • Chronic treatment with any narcotic-containing medications during the previous month.
  • Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
  • Current treatment with disulfiram.
  • More than 6 weeks of abstinence.
  • Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.

Key Trial Info

Start Date :

April 10 1997

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 13 2002

Estimated Enrollment :

159 Patients enrolled

Trial Details

Trial ID

NCT00000450

Start Date

April 10 1997

End Date

February 13 2002

Last Update

April 20 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Psychiatry, University of Miami School of Medicine

Miami, Florida, United States, 33136

Naltrexone Maintenance Treatment of Alcoholism | DecenTrialz