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Vaporized Cannabis and Spinal Cord Injury Pain

This study is currently recruiting participants.
Verified November 2012 by University of California, Davis
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
ClinicalTrials.gov Identifier:
NCT01555983
First received: February 9, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
 Drug: Cannabis
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Analgesia [ Time Frame: within 5 minutes ] [ Designated as safety issue: No ]
    11 point numerical scale


Secondary Outcome Measures:
  • Neuropsychological Testing of Memory [ Time Frame: within 5-20 minutes ] [ Designated as safety issue: No ]
    Hopkins Verbal Learning Test

  • Psychomotor Performance [ Time Frame: within 20-25 minutes ] [ Designated as safety issue: No ]
    Grooved Pegboard Test

  • Attention [ Time Frame: within 25-30 minutes ] [ Designated as safety issue: No ]
    Digit Symbol Test


Estimated Enrollment: 52
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cannabis, High Dose
High Dose: 7.0% THC
 Drug: Cannabis
7.0% THC
Other Name: Vaporized Marijuana, 7.0% THC
Experimental: Cannabis, Low Dose
Low Dose: 3.55% THC
 Drug: Cannabis
3.55% THC
Other Name: Vaporized Marijuana, 3.55% THC
Experimental: Placebo
Placebo: 0% THC
 Drug: Placebo
0% THC
Other Name: Vaporized Placebo

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 and less than 70
  • ASIA A-D spinal cord injury provided neuropathic pain present as defined as neuropathic pain at- and/or below-level due to trauma or disease of the spinal cord or cauda equina with a median pain intensity of 4 on a 0-10 point numeric rating scale (NRS) during a 1-week baseline period. Neuropathic pain will be 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. Below-level pain will be defined as neuropathic pain present more than three dermatomes below the neurological level and at-level pain as pain located within the dermatome at and three dermatomes below the neurological level.
  • Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
  • Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)
  • A negative urine drug screening test, i.e., no evidence of IV drug abuse. If positive for marijuana, subjects must abstain for thirty days and be retested.

Exclusion Criteria:

  • Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer's Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
  • Clinically significant or unstable medical condition (i.e., severe liver disease or impaired renal function) that, in the opinion of the investigator, would compromise participation in the study
  • 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)
  • Active substance abuse within past year using "The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV
  • Current use of marijuana (e.g., within 30 days of randomization)
  • Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
  • Currently on probation or parole.
  • Hx of Schizophrenia, Bipolar Depression with Mania, current suicidal ideation or past history of suicide attempt
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555983

Locations
United States, California
UC Davis CTSC Clinical Research Center , Sacramento VA Medical Center Recruiting
Mather, California, United States, 95655
Contact: Barth Wilsey, MD     916-843-7165     blwilsey@ucdavis.edu    
Principal Investigator: Barth Wilsey, MD            
Sponsors and Collaborators
Barth Wilsey
VA Northern California Health Care System
University of California, San Diego
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Barth Wilsey, MD University of California, Davis
  More Information

Publications:

Responsible Party: Barth Wilsey, Research Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01555983     History of Changes
Other Study ID Numbers: 256412-3, 1R01DA030424-01A1
Study First Received: February 9, 2012
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
cannabis
spinal cord injuries
antinociception

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013