Effect of Ondansetron for Withdrawal Symptoms

This study has been completed.
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
First received: June 9, 2008
Last updated: January 4, 2011
Last verified: January 2011
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ondansetron for Withdrawal Symptoms

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Decrease of withdrawal symptoms [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

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 Drug: Ondansetron and Placebo crossover
Experimental: Ondansetron Drug: Ondansetron and Placebo crossover


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00695864

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

Responsible Party: Sean Mackey, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00695864     History of Changes
Other Study ID Numbers: SU-05222008-1180  14228 
Study First Received: June 9, 2008
Last Updated: January 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Anti-Anxiety Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 22, 2016