Effect of Ondansetron for Withdrawal Symptoms

Substance Withdrawal Syndrome Clinical Trial

Official title:

Effect of Ondansetron for Withdrawal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695864
• Other study ID #: SU-05222008-1180
• Secondary ID: 14228
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: May 9, 2017
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Withdrawal Syndrome

Intervention

Drug:
• Ondansetron and Placebo crossover

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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