drugset / Trial / NCT00661674

Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

NCT00661674 ↗

Completed 10 enrolled Stanford University
RandomizedCrossoverTriple-blindTreatment

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).

Timeline

Start
2008-04
Primary completion
2008-08
Completion
2008-08

Outcome

Met primary endpoint

paper Comparison of average baseline OOWS scores with OOWS scores obtained 15 minutes after naloxone was significant (p = 0.0001). PMID 27712113 ↗

paper Scores from 15 minutes post-naloxone infusion showed significant differences in OOWS scores between treatment groups: placebo, 3.7 ± 2.4; palonosetron, 1.5 ± 0.97; PMID 27712113 ↗

paper Pretreatment with palonosetron significantly reduced many signs of experimentally-induced opioid withdrawal. PMID 27712113 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxyzine Small molecule 100 mg Oral
Subject Palonosetron Other / unclassified 0.75 mg Intravenous