Ondansetron Treatment for Alcoholism

This study has been completed.

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00000443

Purpose

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.

Condition	Intervention	Phase
Alcoholism	Drug: ondansetron (Zofran)	Phase II

MedlinePlus related topics: Alcoholism

Drug Information available for: Ondansetron Ondansetron hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:	Pharmacological Treatment for Alcoholism

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Study Completion Date:

April 2000

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000443

Locations

United States, Texas
Substance Abuse Research Center, University of Texas Health Science Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

Study ID Numbers:	NIAAAJOH10522
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000443
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Alcohol-Related Disorders
Ondansetron
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Pharmacologic Actions

Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009