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Vaporized Cannabis and Spinal Cord Injury Pain

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ClinicalTrials.gov Identifier: NCT01555983
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : January 15, 2016
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
VA Northern California Health Care System
University of California, San Diego
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Barth Wilsey, 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 Spinal Cord Injuries
Spinal Cord Diseases
Intervention Drug: Vaporization of Cannabis
Enrollment 42
Recruitment Details Participants were enrolled via recruitment from the UC Davis Medical Center Spinal Cord Injury Clinic, IRB-approved recruitment letters and newspaper advertisements.
Pre-assignment Details Screening for inclusion criteria (e.g., age > 18 and ≤ 70, pain intensity ≥ 4/10 and Leeds Assessment of Neuropathic Symptoms and Signs, a pain scale based on analysis of sensory description and bedside examination of sensory dysfunction. A threshold of ≥12 on this instrument was utilized to substantiate neuropathic pain.
Arm/Group Title Placebo First, Then 2.9%THC, Then 6.7% THC Placebo First, Then 6.7%THC, Then 2.9%THC 2.9%THC First, Then Placebo, Then 6.7%THC 2.9%THC First, Then 6.7%THC, Then Placebo 6.7%THC First, Then Placebo, Then 2.9%THC 6.7%THC First, Then 2.9%THC, Then Placebo
Hide Arm/Group Description Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period). Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period). 2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period) 2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period). 6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period). 6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
Period Title: Overall Study
Started 9 7 7 7 5 7
Completed 8 [1] 7 7 7 4 [2] 6 [3]
Not Completed 1 0 0 0 1 1
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1             1
[1]
One subject only finished the placebo session, then dropped out of study
[2]
One subject complete 6.7%THC and placebo sessions, then dropped out
[3]
One subject completed the 6.7%THC session, then dropped out.
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants received all interventions
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
Consented subjects with at least one study visit
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
46.4  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
13
  31.0%
Male
29
  69.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
1.Primary Outcome
Title Number of Participants Achieving a Reduction in Pain Intensity of 30% or More
Hide Description Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.
Time Frame hourly pain assessments for 8 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo THC 2.9% THC 6.7% THC
Hide Arm/Group Description:
Session at which placebo THC was administered
Vaporization of Cannabis 2.9% THC
Vaporization of Cannabis 6.7% THC
Overall Number of Participants Analyzed 41 38 41
Measure Type: Number
Unit of Measure: participants
18 26 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo THC, 2.9% THC, 6.7% THC
Comments The number needed to treat (NNT) to achieve 30% pain reduction during the 8-hour period was 4 (95% CI: 2.1-25.3) for the lower dose vs. placebo, and 3 (95% CI: 1.6-4.2) for the higher dose versus placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Cochran-Armitage trend tes
Estimated Value .0001
Estimation Comments [Not Specified]
Time Frame participants were followed for the 8 hour duration of clinical research center stay
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo THC 2.9% THC 6.7% THC
Hide Arm/Group Description Vaporization of Cannabis Placebo THC Vaporization of Cannabis 2.9% THC Vaporization of Cannabis 6.7% THC
All-Cause Mortality
Placebo THC 2.9% THC 6.7% THC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/38 (0.00%)      0/41 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo THC 2.9% THC 6.7% THC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/38 (0.00%)      0/41 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo THC 2.9% THC 6.7% THC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/38 (0.00%)      1/41 (2.44%)    
Cardiac disorders       
orthostatic hypotension * 1 [1]  0/41 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1
1
Term from vocabulary, low blood pressure
*
Indicates events were collected by non-systematic assessment
[1]
Patient had orthostatic hypotension. Symptomatically, he stated he was going to "pass out" and the the room went dark. BP initially unobtainable but returned to baseline with assuming supine position.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Barth Wilsey MD
Organization: UC Davis (currently at UC San Diego)
Phone: 916-402-2270
Responsible Party: Barth Wilsey, University of California, Davis
ClinicalTrials.gov Identifier: NCT01555983     History of Changes
Other Study ID Numbers: 256412
1R01DA030424-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2012
First Posted: March 16, 2012
Results First Submitted: December 3, 2015
Results First Posted: January 15, 2016
Last Update Posted: April 18, 2017