Vaporized Cannabis and Spinal Cord Injury Pain

This study has been completed.
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: January 13, 2016
Last verified: January 2016
  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
Spinal Cord Diseases
Drug: Vaporization of Cannabis
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:


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

Primary Outcome Measures:
  • Number of Participants Achieving a Reduction in Pain Intensity of 30% or More [ Time Frame: hourly pain assessments for 8 hours ] [ Designated as safety issue: No ]
    Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.


Enrollment: 42
Study Start Date: July 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaporization of Cannabis 6.7% THC
Inhaling of standardized measured puffs of Vaporized High Dose 6.7% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Drug: Vaporization of Cannabis
Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC
Other Name: Medical Marijuana
Active Comparator: Vaporization of Cannabis 2.9% THC
Inhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Drug: Vaporization of Cannabis
Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC
Other Name: Medical Marijuana
Placebo Comparator: Vaporization of Cannabis Placebo THC
Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Drug: Vaporization of Cannabis
Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC
Other Name: Medical Marijuana

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mather, California, United States, 95655
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
Results First Received: December 3, 2015
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
cannabis
central neuropathic pain
analgesia

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Marijuana Abuse
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2016