POWS: Palonosetron/Ondansetron Opioid Withdrawal Study
Information source: Stanford University
Information obtained from ClinicalTrials.gov on November 03, 2008
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: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
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
|
