Ondansetron Treatment for Alcoholism

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Pharmacological Treatment for Alcoholism

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on February 09, 2012