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
  Hide Participant Flow

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


  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
  Hide 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


  More Information
  Hide More Information

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
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