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Vaporized Cannabis and Spinal Cord Injury Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01555983
First Posted: March 16, 2012
Last Update Posted: April 18, 2017
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.
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
Results First Submitted: December 3, 2015  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo First, Then 2.9%THC, Then 6.7% THC 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 First, Then 6.7%THC, Then 2.9%THC 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 First, Then Placebo, Then 6.7%THC 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 First, Then 6.7%THC, Then Placebo 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 First, Then Placebo, Then 2.9%THC 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 First, Then 2.9%THC, Then Placebo 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).

Participant Flow:   Overall Study
    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
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 
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.



  Baseline Characteristics
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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.
Consented subjects with at least one study visit

Reporting Groups
  Description
All Study Participants All participants received all interventions

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.4  (13.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  31.0% 
Male      29  69.0% 
Region of Enrollment 
[Units: Participants]
 
United States   42 


  Outcome Measures

1.  Primary:   Number of Participants Achieving a Reduction in Pain Intensity of 30% or More   [ Time Frame: hourly pain assessments for 8 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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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
e-mail: bwilsey@ucsd.edu


Publications:

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