Ondansetron Treatment for 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 NCT00000443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Ondansetron Treatment for Alcoholism
Official Title ^ICMJE	Pharmacological Treatment for Alcoholism
Brief Summary	The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.
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: ondansetron (Zofran)
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
Completion Date	April 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meet criteria for alcohol dependence. Subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder. Understand the requirements of the study and be able to complete the questionnaires and rating scales. Exclusion Criteria: Current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study. Positive urine drug screen test for narcotics, barbiturates, or benzodiazepines. Receiving current psychotropic medications. Current history of other psychiatric disorders excluding nicotine dependence. Hepatocellular disease. Pregnant females.
Gender	Both
Ages	25 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	NCT00000443
Responsible Party
Study ID Numbers ^ICMJE	NIAAAJOH10522
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