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...
Date First Received: April 15, 2008
Last Updated: April 17, 2008
Verified by: Stanford University, April 2008
Clinical Trial Phase: N/A | Start Date: April 2008
Overall Status: Recruiting
Estimated Enrollment: 14
Brief Summary
Official Title: “POWS: Palonosetron/Ondansetron Opioid Withdrawal Study”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: ondansetron
- Drug: palonosetron
- Drug: hydroxyzine
Outcome Measures for this Clinical Trial
Primary Measures
- OOWS score
Secondary Measures
- SOWS score
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- healthy men
- ages 18-35
Exclusion Criteria:
- history of substance abuse
- Raynaud's disease or coronary artery disease
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Stanford University
Overall Clinical Trial Officials and Contacts
Dr Larry Fu-nien Chu Principal Investigator Stanford University
Overall Contact: Lawrence F Chu, MD, MA 650-723-7442 stanfordbackpain@gmail.com
Additional Information
Information obtained from ClinicalTrials.gov on August 21, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661674
Study ID Number: SU-04152008-1099
ClinicalTrials.gov Identifier: NCT00661674
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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