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Completed

NCT Number: NCT00661674

Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

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).

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron

Drug

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 names: Aloxi

hydroxyzine

Drug

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 names: Vistaril, Atarax

Placebo

Other

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

Primary outcomes

  1. OOWS Score

    Time frame: Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)

    The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.

    OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications.

    Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups

Secondary outcomes

  1. SOWS Score

    Time frame: Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration)

    The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.

    The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal.

    Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 18, 2008
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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