Back to resultsEffect of Ondansetron for Withdrawal Symptoms
Primary Purpose
Substance Withdrawal Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ondansetron and Placebo crossover
Sponsored by
About this trial
This is an interventional treatment trial for Substance Withdrawal Syndrome
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo - sugar pill
Ondansetron
Arm Description
Placebo - sugar pill
Ondansetron
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00695864
Brief Title
Effect of Ondansetron for Withdrawal Symptoms
Official Title
Effect of Ondansetron for Withdrawal Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Withdrawal Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo - sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo - sugar pill
Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Ondansetron
Intervention Type
Drug
Intervention Name(s)
Ondansetron and Placebo crossover
Primary Outcome Measure Information:
Title
Change in Withdrawal Symptoms With Placebo and With Ondansetron
Description
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.
Time Frame
Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Mackey
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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Effect of Ondansetron for Withdrawal Symptoms
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