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Ondansetron Treatment for Alcoholism

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ClinicalTrials.gov Identifier: NCT00000443
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 24, 2005
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: ondansetron (Zofran) Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacological Treatment for Alcoholism
Estimated Study Completion Date : April 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000443

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)

ClinicalTrials.gov Identifier: NCT00000443     History of Changes
Other Study ID Numbers: NIAAAJOH10522
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 2002

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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