Effect of Ondansetron for Withdrawal Symptoms

Verified by: Stanford University, January 2011
First Received: June 9, 2008 | Last Updated: January 4, 2011 | Phase: N/A | Start Date: May 2008
Overall Status: Completed | Estimated Enrollment: 31
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We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective...

Brief Summary

Official Title: “Effect of Ondansetron for Withdrawal Symptoms”

We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications.

This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

  • Drug: Ondansetron and Placebo crossover

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: Placebo - sugar pill
  • Experimental: Ondansetron

Outcome Measures for this Clinical Trial

Primary Measures

  • Decrease of withdrawal symptoms
    • Time Frame: Duration of trial
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • Inclusion Criteria:-Over 18 years of age
  • No medical contraindications to medication
  • Able to fulfill research procedures
  • Exclusion Criteria:-Subjects who are unable to respond to our questionnaires or to stimuli as required by the experimental protocol will be excluded.
  • Subjects will be excluded if they have a history of significant psychiatric disorders that would prevent them from engaging in a treatment program.
  • Participating in other studies that would interfere with the procedures in this study
  • Known or apparent pregnancy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Stanford University Other

Overall Clinical Trial Officials and Contacts

Sean Mackey Principal Investigator Stanford University  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00695864

Study ID Number: SU-05222008-1180

ClinicalTrials.gov Identifier: NCT00695864

Health Authority: United States: Institutional Review Board

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