Naltrexone Maintenance Treatment of Alcoholism - Tabular View

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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)

This Tabular View shows the required WHO registration data elements as marked by ^†

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.