NCT00661674

Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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).

Detailed description

We hope to learn if 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.

Conditions

• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	Palonosetron	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
DRUG	Hydroxyzine	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
OTHER	Placebo	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

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-04-18
• Last updated: 2017-06-05
• Results posted: 2017-06-05

Locations

1 site across 1 country: United States