Effect of Ondansetron for Withdrawal Symptoms

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00695864
First received: June 9, 2008
Last updated: January 4, 2011
Last verified: January 2011
  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
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

  Eligibility

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

No publications provided

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
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 20, 2014