Effect of Ondansetron for Withdrawal Symptoms

This study is enrolling participants by invitation only.

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00695864

Purpose

We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.

Condition	Intervention
Substance Withdrawal Syndrome	Drug: Ondansetron

Drug Information available for: Ondansetron Ondansetron hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of Ondansetron for Withdrawal Symptoms

Further study details as provided by Stanford University:

Primary Outcome Measures:

Decrease of withdrawal symptoms

Estimated Enrollment:	40
Study Start Date:	May 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:-Over 18 years of age

No medical contraindications to medication
Able to fulfill research procedures Exclusion Criteria:-Subjects who are unable to respond to our questionnaires or to stimuli as required by the experimental protocol will be excluded.
Subjects will be excluded if they have a history of significant psychiatric disorders that would prevent them from engaging in a treatment program.
Participating in other studies that would interfere with the procedures in this study
Known or apparent pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695864

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Sean Mackey

Stanford University

More Information

Study ID Numbers:	SU-05222008-1180, 14228
Study First Received:	June 9, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00695864
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Substance Withdrawal Syndrome
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Ondansetron
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
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
Pathologic Processes
Autonomic Agents
Syndrome
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009