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Effect of Ondansetron for Withdrawal Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695864
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Substance Withdrawal Syndrome Drug: Ondansetron and Placebo crossover Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ondansetron for Withdrawal Symptoms
Study Start Date : May 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo - sugar pill
Placebo - sugar pill
Drug: Ondansetron and Placebo crossover
Experimental: Ondansetron
Drug: Ondansetron and Placebo crossover

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695864

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Sean Mackey Stanford University

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Responsible Party: Sean Mackey, Principle Investigator, Stanford University Identifier: NCT00695864    
Other Study ID Numbers: SU-05222008-1180
First Posted: June 12, 2008    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents