POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

This study is currently recruiting participants.

Verified by Stanford University, April 2008

First Received: April 15, 2008 Last Updated: April 17, 2008 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00661674

Purpose

Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).

Condition	Intervention
Substance-Related Disorders	Drug: ondansetron Drug: palonosetron Drug: hydroxyzine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Resource links provided by NLM:

Drug Information available for: Hydroxyzine Hydroxyzine pamoate Ondansetron hydrochloride Ondansetron RS 25233-197 Palonosetron Hydrochloride Hydroxyzine dihydrochloride

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

OOWS score

Secondary Outcome Measures:

SOWS score

Estimated Enrollment:	14
Study Start Date:	April 2008

Detailed Description:

We hope to learn if Ondansetron, Palonosetron, and/or combination with hydroxyzine can be used to prevent or attenuate the signs and symptoms of opioid withdrawal. If we find that it can help prevent these symptoms, it may become a new treatment that can aid patients suffering from these symptoms.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy men
ages 18-35

Exclusion Criteria:

history of substance abuse
Raynaud's disease or coronary artery disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661674

Contacts

Contact: Lawrence F Chu, MD, MA

650-723-7442

stanfordbackpain@gmail.com

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Lawrence F Chu, MD, MA 650-723-7442 stanfordbackpain@gmail.com
Principal Investigator: Dr Larry Fu-nien Chu

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Dr Larry Fu-nien Chu

Stanford University

More Information

No publications provided

Study ID Numbers:	SU-04152008-1099, eprotocol 11004
Study First Received:	April 15, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00661674 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Antiemetics
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Antipruritics
Ondansetron
Dermatologic Agents
Tranquilizing Agents

Gastrointestinal Agents
Central Nervous System Depressants
Histamine Agents
Antipsychotic Agents
Pharmacologic Actions
Hydroxyzine
Palonosetron
Serotonin Agents
Histamine Antagonists
Autonomic Agents
Histamine H1 Antagonists
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009