Naltrexone Maintenance Treatment of Alcoholism - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Naltrexone Maintenance Treatment of Alcoholism
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Alcoholism
Intervention ^ICMJE	Drug: naltrexone (Revia)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	184
Completion Date	April 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000450
Responsible Party
Study ID Numbers ^ICMJE	NIAAAMAS10518
Study Sponsor ^ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	August 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP