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POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Information source: Stanford University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Substance-Related Disorders

Intervention: ondansetron (Drug); palonosetron (Drug); hydroxyzine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Dr Larry Fu-nien Chu, Principal Investigator, Affiliation: Stanford University

Overall contact:
Lawrence F Chu, MD, MA, Phone: 650-723-7442, Email: stanfordbackpain@gmail.com

Summary

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).

Clinical Details

Official title: POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: OOWS score

Secondary outcome: SOWS score

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- healthy men

- ages 18-35

Exclusion Criteria:

- history of substance abuse

- Raynaud's disease or coronary artery disease

Locations and Contacts

Lawrence F Chu, MD, MA, Phone: 650-723-7442, Email: stanfordbackpain@gmail.com

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

Starting date: April 2008
Last updated: April 17, 2008

Page last updated: December 08, 2011

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