Ondansetron Treatment for Alcoholism

This study has been completed.

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
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

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

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Antiemetics
Antipsychotic Agents
Serotonin

Mental Disorders
Alcoholism
Substance-Related Disorders
Antipruritics
Anti-Anxiety Agents
Alcohol-Related Disorders
Ondansetron
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Disorders of Environmental Origin
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Antipruritics
Alcohol-Related Disorders
Ondansetron

Dermatologic Agents
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Alcoholism
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009