Effects of Vaporized Marijuana on Neuropathic Pain

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. Identifier: NCT01037088
Recruitment Status : Completed
First Posted : December 21, 2009
Results First Posted : April 9, 2013
Last Update Posted : January 31, 2018
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Information provided by (Responsible Party):
University of California, Davis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Neuropathic Pain
Reflex Sympathetic Dystrophy
Peripheral Neuropathy
Post-herpetic Neuralgia
Spinal Cord Injury
Multiple Sclerosis
Interventions: Drug: Mild dose cannabis
Drug: Low dose cannabis
Drug: Cannabis

  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
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
Received 3.53% THC   36 
Received 1.29% THC   37 
Received Placebo   38 
Withdrawal by Subject                3 

  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
All Participants All participants who were randomized

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      39 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 50  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      11  28.2% 
Male      28  71.8% 
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 ]

2.  Secondary:   Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis   [ Time Frame: baseline to six hours ]

  Serious Adverse Events

  Other Adverse Events

  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

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


Responsible Party: University of California, Davis Identifier: NCT01037088     History of Changes
Other Study ID Numbers: 200614658
C06-DA-119 ( Other Grant/Funding Number: Center for Medicinal Cannabis Research )
First Submitted: December 17, 2009
First Posted: December 21, 2009
Results First Submitted: December 6, 2012
Results First Posted: April 9, 2013
Last Update Posted: January 31, 2018