Effects of Vaporized Marijuana on Neuropathic Pain
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| ClinicalTrials.gov Identifier: NCT01037088 |
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Recruitment Status :
Completed
First Posted : December 21, 2009
Results First Posted : April 9, 2013
Last Update Posted : January 31, 2018
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Sponsor:
University of California, Davis
Collaborators:
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Information provided by (Responsible Party):
University of California, Davis
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| 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 |
Participant Flow
| 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 |
|---|---|
 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 |
Baseline Characteristics
| Arm/Group Title | All Participants | |
|---|---|---|
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Arm/Group Description |
All participants who were randomized | |
| Overall Number of Baseline Participants | 39 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 39 participants | |
| <=18 years |
0 0.0%
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| Between 18 and 65 years |
39 100.0%
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| >=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 39 participants | |
| 50 (11) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 39 participants | |
| Female |
11 28.2%
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| Male |
28 71.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 39 participants |
| 39 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
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
Results Point of Contact
| Name/Title: | Dr. Barth Wilsey, MD |
| Organization: | UCaliforniaDavis |
| Phone: | 916-843-9082 |
| EMail: | blwilsey@ucdavis.edu |
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT01037088 |
| 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 |