N/A
Completed N=10
Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
Source: ClinicalTrials.gov NCT00661674 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: OOWS Score — 3.5; 1.0; 0 units on a scale (OOWS Scale) — p=0.0001
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).
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 |
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. Informational only — not medical advice.