Ondansetron Treatment for Alcoholism - Tabular View

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Ondansetron Treatment for Alcoholism

This study has been completed.

Study NCT00000443. 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 ^†	Ondansetron Treatment for Alcoholism
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alcoholism
Intervention ^†	Drug: ondansetron (Zofran)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date	April 2000
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00000443
Organization ID	NIAAAJOH10522
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	August 2002
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.