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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
Enrollment 44
Recruitment Details 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 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.
Arm/Group Title All Participants
Hide Arm/Group Description All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
Period Title: Overall Study
Started 39
Received 3.53% THC 36
Received 1.29% THC 37
Received Placebo 38
Completed 36
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title All Participants
Hide Arm/Group Description All participants who were randomized
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
39
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
50  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
11
  28.2%
Male
28
  71.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Participants With 30% or Greater Reduction in Pain Intensity
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mild Dose Cannabis Low Dose Cannabis Placebo Cannabis
Hide Arm/Group Description:
3.53% THC by weight
1.29% THC by weight
trace THC by weight
Overall Number of Participants Analyzed 36 37 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61
(45 to 75)
57
(41 to 71)
26
(15 to 42)
2.Secondary Outcome
Title Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis
Hide Description The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). 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).
Time Frame baseline to six hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild Dose Cannabis Low Dose Cannabis Placebo Cannabis
Hide Arm/Group Description:
3.53% THC by weight
1.29% THC by weight
0.00% THC by weight
Overall Number of Participants Analyzed 36 37 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline prior to Administration of Cannabis 57.3  (24.1) 54.4  (23.4) 57.5  (22.8)
Hour 1 after Administration of Cannabis 51.8  (22.1) 49.8  (25.7) 56.5  (24.1)
Hour 2 after Administration of Cannabis 44.3  (26.8) 45.8  (26.4) 55.4  (25.1)
Hour 3 after Administration of Cannabis 39.7  (25.8) 38.2  (27.1) 50.7  (25.0)
Hour 4 after Administration of Cannabis 40.4  (26.9) 39.5  (27.2) 48.1  (25.6)
Hour 5 after Administration of Cannabis 41.7  (25.5) 40.7  (27.2) 51.8  (25.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Dose Cannabis, Low Dose Cannabis, Placebo Cannabis
Comments Hour 1 after Administration of Cannabis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments not significant
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mild Dose Cannabis, Low Dose Cannabis, Placebo Cannabis
Comments Hour 2 after Administration of Cannabis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mild Dose Cannabis, Low Dose Cannabis, Placebo Cannabis
Comments Hour 3 after Administration of Cannabis (after the second inhalation of cannabis)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mild Dose Cannabis, Low Dose Cannabis, Placebo Cannabis
Comments Hour 4 after Administration of Cannabis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Mild Dose Cannabis, Low Dose Cannabis, Placebo Cannabis
Comments Hour 5 after Administration of Cannabis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.0018
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mild Dose Cannabis Low Dose Cannabis Placebo Cannabis
Hide Arm/Group Description 3.53% 9-delta tetrahydrocannabinol by weight 1.29% 9-delta tetrahydrocannabinol by weight 0% 9-delta tetrahydrocannabinol by weight
All-Cause Mortality
Mild Dose Cannabis Low Dose Cannabis Placebo Cannabis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mild Dose Cannabis Low Dose Cannabis Placebo Cannabis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/37 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mild Dose Cannabis Low Dose Cannabis Placebo Cannabis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/37 (0.00%)   0/38 (0.00%) 
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
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
ClinicalTrials.gov 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