Effect of Ondansetron for Withdrawal Symptoms - Full Text View

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 and Placebo crossover

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
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 ]

Enrollment:	31
Study Start Date:	May 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo - sugar pill	Drug: Ondansetron and Placebo crossover
Experimental: Ondansetron	Drug: Ondansetron and Placebo crossover

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:	Sean Mackey, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00695864 History of Changes
Other Study ID Numbers:	SU-05222008-1180, 14228
Study First Received:	June 9, 2008
Last Updated:	January 4, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Substance Withdrawal Syndrome
Substance-Related Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on February 09, 2012