Effect of Ondansetron for Withdrawal Symptoms
2 other identifiers
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
May 15, 2017
CompletedMay 15, 2017
May 1, 2017
1.2 years
June 9, 2008
November 13, 2015
May 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Withdrawal Symptoms With Placebo and With 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
Study Arms (2)
Placebo - sugar pill
PLACEBO COMPARATORPlacebo - sugar pill
Ondansetron
EXPERIMENTALOndansetron
Interventions
Eligibility Criteria
You may qualify if:
- No medical contraindications to medication
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Mackey
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 12, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 15, 2017
Results First Posted
May 15, 2017
Record last verified: 2017-05