Effect of Ondansetron for Withdrawal Symptoms

May 9, 2017 updated by: Sean Mackey, Stanford University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo - sugar pill
Drug: Ondansetron and Placebo crossover
Experimental: Ondansetron
Drug: Ondansetron and Placebo crossover

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Withdrawal Symptoms With Placebo and With Ondansetron
Time Frame: Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron
Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity.
Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sean Mackey, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 12, 2008

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-05222008-1180
  • 14228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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