Sertraline and Naltrexone for Alcohol Dependence - 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 NCT00000440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Sertraline and Naltrexone for Alcohol Dependence
Official Title ^ICMJE	Sertraline and Naltrexone for Alcohol Dependents
Brief Summary	This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Alcoholism
Intervention ^ICMJE	Drug: naltrexone (Revia) Drug: sertraline (Zoloft)
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	124
Completion Date	September 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meets the criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days and not greater than 30 days. Able to read English and complete study evaluations. A stable residence and a telephone to ensure that subjects can be located during the study. Exclusion Criteria: Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence. Current use of disulfiram (Antabuse) or a MAO Inhibitor. Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania). Major depression at the time of assessment. Previous treatment with naltrexone (Revia) for alcohol dependence. Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease. Abstinent longer than 30 days prior to admission to program. Hepatocellular disease or elevated bilirubin levels. Females who are pregnant, nursing, or not using a reliable method of birth control.
Gender	Both
Ages	18 Years to 55 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	NCT00000440
Responsible Party
Study ID Numbers ^ICMJE	NIAAAFAR11222
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