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Effect of Ondansetron for Withdrawal Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695864
First Posted: June 12, 2008
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean Mackey, Stanford University
Results First Submitted: November 13, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Substance Withdrawal Syndrome
Intervention: Drug: Ondansetron and Placebo crossover

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 31 patients enrolled, 17 did not experience withdrawal symptoms and were therefore not assigned an intervention.

Reporting Groups
  Description
Placebo Then Ondansetron

Dosage and form:

Placebo - tablet Odansetron - 8 mg oral tablet

Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron.


Participant Flow for 2 periods

Period 1:   Placebo
    Placebo Then Ondansetron
STARTED   14 
COMPLETED   9 
NOT COMPLETED   5 
Withdrawal by Subject                1 
Physician Decision                4 

Period 2:   Ondansetron
    Placebo Then Ondansetron
STARTED   14 
COMPLETED   9 
NOT COMPLETED   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Then Ondansetron

Dosage and form:

Placebo - tablet Odansetron - 8 mg oral tablet

Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron.


Baseline Measures
   Placebo Then Ondansetron 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Full Range)
 42.8 
 (27 to 55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  42.9% 
Male      8  57.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   14 


  Outcome Measures

1.  Primary:   Change in Withdrawal Symptoms With Placebo and With Ondansetron   [ Time Frame: Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Organization: Stanford University
phone: (650) 498-6477
e-mail: smackey@pain.stanford.edu



Responsible Party: Sean Mackey, Stanford University
ClinicalTrials.gov Identifier: NCT00695864     History of Changes
Other Study ID Numbers: SU-05222008-1180
14228
First Submitted: June 9, 2008
First Posted: June 12, 2008
Results First Submitted: November 13, 2015
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017