The present study will be designed to evaluate the analgesic effects of vaporized cannabis in patients with neuropathic pain due to spinal cord injury. A within-subject crossover study of the effects of cannabis (3.5% and 7.0% delta-9-THC) versus placebo on spontaneous and evoked pain will be performed. Both pain intensity and pain unpleasantness will be assessed to see if marijuana affects sensory-discriminative pain more or less than the motivational-affective component. If present, areas of mechanical allodynia will be assessed with repeated testing to determine the degree of the allodynia regression (if any) after inhaling cannabis via a vaporizer. Heat evoked pain will be studied using mild to moderately painful heat stimuli delivered to the painful area of the subject's body using an electronically controlled Peltier contact thermode via a Medoc TSA 2001 quantitative sensory tester. Neuropsychological functioning (attention, learning and memory, and psychomotor performance) will be evaluated with the Digit Symbol Modalities Test, the Hopkins Verbal Learning Test, the Grooved Pegboard Test Trail Making Test and the Paced Auditory Serial Addition Test (PASAT) before and after the administration of vaporized cannabis. Emotional responses will be evaluated using the Profile of Moods States. The degree of antinociception will then be compared with neuropsychological and mood effects of cannabis for a synopsis of the relative effectiveness (i.e., efficacy versus side-effects) of the doses employed. The major hypothesis will be that vaporized cannabis can induce antinociceptive changes in spontaneous and evoked pain in subjects with neuropathic pain. The second hypothesis will be that the higher dose of cannabis (7.0%) employed will induce the same or a greater degree of antinociception that is not independent of differences in mood, cognition, and psychomotor performance.

Public Health Relevance

This study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition and psychomotor performance will also be measured.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
1R01DA030424-01A1
Application #
8186386
Study Section
Acute Neural Injury and Epilepsy Study Section (ANIE)
Program Officer
Lin, Yu
Project Start
2011-09-15
Project End
2014-07-31
Budget Start
2011-09-15
Budget End
2012-07-31
Support Year
1
Fiscal Year
2011
Total Cost
$256,289
Indirect Cost
Name
University of California Davis
Department
Anesthesiology
Type
Schools of Medicine
DUNS #
047120084
City
Davis
State
CA
Country
United States
Zip Code
95618
Wilsey, Barth; Marcotte, Thomas D; Deutsch, Reena et al. (2016) An Exploratory Human Laboratory Experiment Evaluating Vaporized Cannabis in the Treatment of Neuropathic Pain From Spinal Cord Injury and Disease. J Pain 17:982-1000
Wilsey, Barth; Deutsch, Reena; Marcotte, Thomas D (2016) Maintenance of Blinding in Clinical Trials and the Implications for Studying Analgesia Using Cannabinoids. Cannabis Cannabinoid Res 1:139-148
Wilsey, Barth L; Deutsch, Reena; Samara, Emil et al. (2016) A preliminary evaluation of the relationship of cannabinoid blood concentrations with the analgesic response to vaporized cannabis. J Pain Res 9:587-98
Wilsey, Barth; Atkinson, J Hampton; Marcotte, Thomas D et al. (2015) The Medicinal Cannabis Treatment Agreement: Providing Information to Chronic Pain Patients Through a Written Document. Clin J Pain 31:1087-96
Wilsey, Barth; Marcotte, Thomas; Deutsch, Reena (2013) Response to Stacey and Moller's letter to the editor. J Pain 14:1252-3
Wilsey, Barth; Marcotte, Thomas; Deutsch, Reena et al. (2013) Low-dose vaporized cannabis significantly improves neuropathic pain. J Pain 14:136-48
Grant, Igor; Atkinson, J Hampton; Gouaux, Ben et al. (2012) Medical marijuana: clearing away the smoke. Open Neurol J 6:18-25