Naltrexone for Relapse Prevention - 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 NCT00000442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Naltrexone for Relapse Prevention
Official Title ^ICMJE	Etiology and Treatment of Alcohol Dependence
Brief Summary	This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Placebo Control, Parallel Assignment, Safety/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	57
Completion Date	December 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 3 days prior to beginning of study. Able to read English and complete study evaluations. Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control. Exclusion Criteria: Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis. Prior history of opioid dependence. Regular use of psychoactive drugs including anxiolytics and antidepressants. Prior treatment with naltrexone. Current use of disulfiram. Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania). Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease. Abstinent longer than 28 days prior to randomization.
Gender	Both
Ages	18 Years to 60 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	NCT00000442
Responsible Party
Study ID Numbers ^ICMJE	NIAAAKRA3510
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	November 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP