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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1
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, United States, 33136