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Naltrexone Maintenance Treatment of Alcoholism

This study has been completed.
Study NCT00000450.   Last updated on June 23, 2005.   Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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Descriptive Information Fields
Brief Title  Naltrexone Maintenance Treatment of Alcoholism
Official Title  Nalmefene Maintenance Treatment of Alcoholism
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 treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.

Detailed Description
Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Alcoholism
Intervention  Drug: naltrexone (Revia)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  184
Start Date 
Completion Date April 2002
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.
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000450
Organization ID NIAAAMAS10518
Secondary IDs ††
Study Sponsor  National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ††
Investigators 
Information Provided By National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date August 2002
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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