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POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Larry Fu-nien Chu, Stanford University
ClinicalTrials.gov Identifier:
NCT00661674
First received: April 15, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  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).


Condition Intervention
Substance-Related Disorders
 Drug: palonosetron
Drug: hydroxyzine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • OOWS score [ Time Frame: The OOWS score will be measure 5 times during the study visit, at T=0 minutes, T=10 minutes, T=145 minutes, T=170 minutes, and T=180 minutes. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • SOWS score [ Time Frame: The SOWS score will be measure 5 times during the study visit, at T=0 minutes, T=10 minutes, T=145 minutes, T=170 minutes, and T=180 minutes. ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

We hope to learn if Ondansetron, 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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men
  • ages 18-35

Exclusion Criteria:

  • history of substance abuse
  • Raynaud's disease or coronary artery disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661674

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr Larry Fu-nien Chu Stanford University
  More Information

No publications provided

Responsible Party: Larry Fu-nien Chu, Associate Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT00661674     History of Changes
Other Study ID Numbers: SU-04152008-1099, eprotocol 11004
Study First Received: April 15, 2008
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Substance-Related Disorders
Mental Disorders
Hydroxyzine
Ondansetron
Palonosetron
Analgesics, Opioid
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Analgesics

ClinicalTrials.gov processed this record on May 16, 2013