Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

Trial ID or NCT#

NCT00661674

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 35 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - Healthy males - Ages 18-35 - No allergies to morphine or palonosetron - No history of addiction or substance abuse
Exclusion Criteria:
  1. - Female - Younger than 18 or older than 35 - History of substance abuse - Raynaud's disease or coronary artery disease - Allergies to morphine or palonosetron
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Investigator(s)

Lawrence Chu, MD, MS
Lawrence Chu, MD, MS
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine

View on ClinicalTrials.gov