At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Examination of Palonosetron and Hydroxyzine Pre-treatment as a Possible Method to Reduce the Objective Signs of Experimentally-induced Acute Opioid Withdrawal in Humans: a Double-blind, Randomized, Placebo-controlled Crossover Study
In Brief
A clinical study evaluating Palonosetron, Hydroxyzine, and 1 other intervention for Substance-Related Disorders. Completed, enrolled 10 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO