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Effects of Vaporized Marijuana on Neuropathic Pain

This study has been completed.
Sponsor:
Collaborators:
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01037088
First received: December 17, 2009
Last updated: April 5, 2013
Last verified: April 2013
Results First Received: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Neuropathic Pain
Reflex Sympathetic Dystrophy
Peripheral Neuropathy
Post-herpetic Neuralgia
Spinal Cord Injury
Multiple Sclerosis
Intervention: Drug: Cannabis

  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
Recruitment took place at the UCDMC and VA Northern California Pain clinics,UCDMC Spinal Cord Injury Clinic, and newspaper advertisements. Between December 2009 and March 2011, 59 patients were consented to enroll in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty subjects did not receive study medication: 9 withdrew for various reasons and 11 were disqualified following a medical evaluation with subsequent disclosure of exclusionary criteria on a physical exam or laboratory finding.

Reporting Groups
  Description
All Participants All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.

Participant Flow:   Overall Study
    All Participants
STARTED   39 
Received 3.53% THC   36 
Received 1.29% THC   37 
Received Placebo   38 
COMPLETED   36 
NOT COMPLETED   3 
Withdrawal by Subject                3 



  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
All Participants All participants who were randomized

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   39 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (11) 
Gender 
[Units: Participants]
 
Female   11 
Male   28 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures

1.  Primary:   Participants With 30% or Greater Reduction in Pain Intensity   [ Time Frame: baseline to six hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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: Dr. Barth Wilsey, MD
Organization: UCaliforniaDavis
phone: 916-843-9082
e-mail: blwilsey@ucdavis.edu


Publications:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01037088     History of Changes
Other Study ID Numbers: 200614658
C06-DA-119 ( Other Grant/Funding Number: Center for Medicinal Cannabis Research )
Study First Received: December 17, 2009
Results First Received: December 6, 2012
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration