Effect of Ondansetron for Withdrawal Symptoms

Not Applicable

Completed

• Conditions: Substance Withdrawal Syndrome
• Interventions: Drug: Ondansetron and Placebo crossover

• Registration Number: NCT00695864
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2015-11-13
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-09
• Last Update Submitted: 2017-05-09
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

-Over 18 years of age

• No medical contraindications to medication
• Able to fulfill research procedures

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo - sugar pill	Ondansetron and Placebo crossover	Placebo - sugar pill
Ondansetron	Ondansetron and Placebo crossover	Ondansetron

Primary Outcome Measures

Name	Time	Method
Change in Withdrawal Symptoms With Placebo and With Ondansetron	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States