POWS: Palonosetron/Ondansetron Opioid Withdrawal Study
Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Substance-Related Disorders
Intervention: palonosetron (Drug); hydroxyzine (Drug)
Sponsored by: Stanford University
Official(s) and/or principal investigator(s):
Dr Larry Fu-nien Chu, Principal Investigator, Affiliation: Stanford University
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).
Official title: POWS: Palonosetron/Ondansetron Opioid Withdrawal Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: OOWS score
Secondary outcome: SOWS score
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.
Minimum age: 18 Years.
Maximum age: 35 Years.
- healthy men
- ages 18-35
- history of substance abuse
- Raynaud's disease or coronary artery disease
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Starting date: April 2008
Last updated: June 5, 2012