Sertraline and Naltrexone for Alcohol Dependence - Tabular View

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Sertraline and Naltrexone for Alcohol Dependence

This study has been completed.

Study NCT00000440. 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 ^†	Sertraline and Naltrexone for Alcohol Dependence
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alcoholism
Intervention ^†	Drug: naltrexone (Revia) Drug: sertraline (Zoloft)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	124
Start Date ^†
Completion Date	September 2002
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00000440
Organization ID	NIAAAFAR11222
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	November 2004
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.