N/A
N=10
Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00661674 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: OOWS Score — 3.5; 1.0; 0 units on a scale (OOWS Scale) — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Palonosetron (Drug); Hydroxyzine (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Stanford University
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OOWS Score |
3.5; 1.0; 0 | 0.0001 sig |
| SECONDARY SOWS Score |
6.0; 4.0; 3.5 | 0.2244 |
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).
Eligibility Criteria
Inclusion Criteria
- Healthy males
- Ages 18-35
- No allergies to morphine or palonosetron
- No history of addiction or substance abuse
Exclusion Criteria
- Female
- Younger than 18 or older than 35
- History of substance abuse
- Raynaud's disease or coronary artery disease
- Allergies to morphine or palonosetron
Data sourced from ClinicalTrials.gov (NCT00661674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.