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  
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 ]
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Measure Type Primary
Measure Title Participants With 30% or Greater Reduction in Pain Intensity
Measure Description The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.
Time Frame baseline to six hours  
Safety Issue No  

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.
This was a cross over study. Ten of the 38 subjects who were exposed to placebo had a 30% reduction in pain intensity as compared to 21 of the 37 exposed to the low dose and 22 of the 36 receiving the medium dose of cannabis.

Reporting Groups
  Description
Mild Dose Cannabis 3.53% THC by weight
Low Dose Cannabis 1.29% THC by weight
Placebo Cannabis trace THC by weight

Measured Values
    Mild Dose Cannabis     Low Dose Cannabis     Placebo Cannabis  
Number of Participants Analyzed  
[units: participants]
  36     37     38  
Participants With 30% or Greater Reduction in Pain Intensity  
[units: percentage¬†of¬†participants]
Number ( 95% Confidence Interval )
  61  
  ( 45 to 75 )  
  57  
  ( 41 to 71 )  
  26  
  ( 15 to 42 )  

No statistical analysis provided for Participants With 30% or Greater Reduction in Pain Intensity




  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