Effect of Ondansetron for Withdrawal Symptoms

This study is ongoing, but not recruiting participants.

First Received: June 9, 2008 Last Updated: February 26, 2010 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Decrease of withdrawal symptoms [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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

No publications provided

Responsible Party:	Stanford University School of Medicine ( Sean Mackey )
Study ID Numbers:	SU-05222008-1180, 14228
Study First Received:	June 9, 2008
Last Updated:	February 26, 2010
ClinicalTrials.gov Identifier:	NCT00695864 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Substance Withdrawal Syndrome
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Disorders of Environmental Origin
Antiemetics
Antipsychotic Agents
Pharmacologic Actions

Serotonin Antagonists
Serotonin Agents
Mental Disorders
Autonomic Agents
Therapeutic Uses
Substance-Related Disorders
Antipruritics
Anti-Anxiety Agents
Ondansetron
Peripheral Nervous System Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on March 11, 2010