POWS: Palonosetron/Ondansetron Opioid Withdrawal Study - Tabular View

Tracking Information

First Received Date ^ICMJE

April 15, 2008

Last Updated Date

April 17, 2008

Start Date ^ICMJE

April 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

OOWS score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00661674 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SOWS score

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Official Title ^ICMJE

POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Brief 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).

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Substance-Related Disorders

Intervention ^ICMJE

Drug: ondansetron
Drug: palonosetron
Drug: hydroxyzine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy men
ages 18-35

Exclusion Criteria:

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

Gender

Male

Ages

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Lawrence F Chu, MD, MA

650-723-7442

stanfordbackpain@gmail.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00661674

Responsible Party

Study ID Numbers ^ICMJE

SU-04152008-1099, eprotocol 11004

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dr Larry Fu-nien Chu

Stanford University

Information Provided By

Stanford University

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP