Clinical trial NCT01555983: Vaporized Cannabis and Spinal Cord Injury Pain
Official title: The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: cannabis
central neuropathic pain
analgesia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: VA Northern California Health Care System
name: University of California, San Diego
name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study will demonstrate that vaporized cannabis can produce antinociceptive effects compared to placebo in human subjects with spinal cord injury (SCI). A within-subject crossover study of the effects of cannabis versus placebo on spontaneous and evoked pain will be performed. A synopsis of antinociception with mood, cognitive impairment, psychomotor performance, and side effects will be obtained to help evaluate the utility of vaporized marijuana in SCI neuropathic pain.

This study will compare the analgesic and side effect profile of low (3.5%) to high dose (7.0%) delta 9-tetrahydrocannabinol in subjects with spinal cord injury pain. It is hypothesized that a low dose will produce a lesser degree of neuropsychological impairment while maintaining a similar degree of pain relief to the higher dose. The use of two different strengths will help determine tolerable dosing for the treatment of SCI neuropathic pain.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 and less than 70
2. Pain intensity ≥ 4/10
3. Neuropathic pain defined as chronic pain in an area of sensory abnormality corresponding to the spinal cord or nerve root lesion, and the pain should have no primary relation to movement, inflammation or other local tissue damage
4. Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
5. Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)

Exclusion Criteria:

1. Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer's Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
2. Clinically significant or unstable medical condition (i.e., cardiac, respiratory, hepatic or renal disease) that, in the opinion of the investigator, would compromise participation in the study
3. Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (hereditary neuropathies; diabetic peripheral neuropathy; traumatic neuropathy; and immune-mediated neuropathies)
4. Active substance abuse within past year using "The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV
5. Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
6. Currently on probation or parole.
7. Hx of Schizophrenia, Bipolar Depression with Mania, current suicidal ideation or past history of suicide attempt 8. Severe depression (Patient Health Questionnaire-9 ≥ 15) 9. Current suicidal ideation

Primary outcomes:
measure: Number of Participants Achieving a Reduction in Pain Intensity of 30% or More
timeFrame: hourly pain assessments for 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mather
country: United States
facility: UC Davis CTSC Clinical Research Center , Sacramento VA Medical Center
state: California
Study officials:
affiliation: UC San Diego, Department of Psychiatry
name: Barth Wilsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.
citation: Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
citation: Abrams DI, Vizoso HP, Shade SB, Jay C, Kelly ME, Benowitz NL. Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. doi: 10.1038/sj.clpt.6100200. Epub 2007 Apr 11.
citation: Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.
citation: Wallace M, Schulteis G, Atkinson JH, Wolfson T, Lazzaretto D, Bentley H, Gouaux B, Abramson I. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology. 2007 Nov;107(5):785-96. doi: 10.1097/01.anes.0000286986.92475.b7.