Clinical trial NCT00661674: Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Palonosetron
Hydroxyzine
Acute opioid withdrawal
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-04-18
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There were three treatment arms to the study: Placebo, Palonosetron, and Palonosetron + Hydroxyzine (Combo). Participants were not randomized in between these arms, all participants completed each arm of the study in a cross-over study methodology (Placebo, Palonosetron, Palonosetron + Hydroxyzene (combo). Participants were individually randomized into the order in which they participated in each arm.

Per sequence each individual participant underwent the following randomization schedule:

Participant 1: Placebo, Combo, Palonosetron Participant 2: Palonosetron, Combo, Placebo Participant 3: Palonosetron, Combo, Placebo Participant 4: Combo, Placebo, Palonosetron Participant 5: Placebo, Palonosetron, Combo Participant 6: Combo, Palonosetron, Placebo Participant 7: Combo, Placebo, Palonosetron Participant 8: Combo, Palonosetron, Placebo Participant 9: Palonosetron, Placebo, Combo Participant 10: Placebo, Combo, Palonosetron
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: OOWS Score
timeFrame: Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)
Secondary outcomes:
measure: SOWS Score
timeFrame: Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr Larry Fu-nien Chu
role: PRINCIPAL_INVESTIGATOR
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