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Effects of Vaporized Marijuana on Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01037088
Recruitment Status : Completed
First Posted : December 21, 2009
Results First Posted : April 9, 2013
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
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
  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

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]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      39 100.0% 
>=65 years      0   0.0% 
Age 
[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

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Mild Dose Cannabis 3.53% 9-delta tetrahydrocannabinol by weight
Low Dose Cannabis 1.29% 9-delta tetrahydrocannabinol by weight
Placebo Cannabis 0% 9-delta tetrahydrocannabinol by weight

Serious Adverse Events
    Mild Dose Cannabis   Low Dose Cannabis   Placebo Cannabis
Total, Serious Adverse Events       
# participants affected / at risk   0/36 (0.00%)   0/37 (0.00%)   0/38 (0.00%) 




  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