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Effect of Ondansetron for Withdrawal Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695864
First Posted: June 12, 2008
Last Update Posted: May 15, 2017
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.
Information provided by (Responsible Party):
Sean Mackey, Stanford University
  Purpose
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 Intervention
Substance Withdrawal Syndrome Drug: Ondansetron and Placebo crossover

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ondansetron for Withdrawal Symptoms

Resource links provided by NLM:


Further study details as provided by Sean Mackey, Stanford University:

Primary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo - sugar pill
Placebo - sugar pill
Drug: Ondansetron and Placebo crossover
Experimental: Ondansetron
Ondansetron
Drug: Ondansetron and Placebo crossover

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00695864


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

Responsible Party: Sean Mackey, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00695864     History of Changes
Other Study ID Numbers: SU-05222008-1180
14228
First Submitted: June 9, 2008
First Posted: June 12, 2008
Results First Submitted: November 13, 2015
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
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