We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ondansetron Treatment for Alcoholism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000443
First Posted: November 3, 1999
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacological Treatment for Alcoholism

Resource links provided by NLM:


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

Estimated Study Completion Date: April 2000
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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


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

ClinicalTrials.gov Identifier: NCT00000443     History of Changes
Other Study ID Numbers: NIAAAJOH10522
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: December 9, 2005
Last Verified: August 2002

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