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


  Baseline Characteristics
  Hide Baseline Characteristics

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  
Number of Participants  
[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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
Inclusion of patients with complex regional pain syndrome type I. In the past, there was no doubt that this disorder should be classified as classical neuropathic pain condition; Unmasking of blinding secondary to the psychoactive effects of cannabis  


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
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