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Vaporized Cannabis and Spinal Cord Injury Pain

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ClinicalTrials.gov Identifier: NCT01555983
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : January 15, 2016
Last Update Posted : April 18, 2017
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

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE March 16, 2012
Results First Submitted Date  ICMJE December 3, 2015
Results First Posted Date  ICMJE January 15, 2016
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Number of Participants Achieving a Reduction in Pain Intensity of 30% or More [ Time Frame: hourly pain assessments for 8 hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
Analgesia [ Time Frame: within 30 minutes ]
antinociception
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
  • Neuropsychological Testing of Memory [ Time Frame: within 30 minutes ]
    Hopkins Verbal Learning Test
  • Psychomotor Performance [ Time Frame: within 30-45 minutes ]
    Grooved Pegboard Test
  • Neuropsychological Testing of Attention [ Time Frame: within 45-60 minutes ]
    Digit Symbol Test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaporized Cannabis and Spinal Cord Injury Pain
Official Title  ICMJE The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Spinal Cord Diseases
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Vaporization of Cannabis
  • 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.
    Intervention: Drug: Vaporization of Cannabis
  • Placebo Comparator: Vaporization of Cannabis Placebo THC
    Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
    Intervention: Drug: Vaporization of Cannabis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2014)
42
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2012)
52
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01555983
Other Study ID Numbers  ICMJE 256412
1R01DA030424-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: email Barth Wilsey at bwilsey@ucsd.edu
Responsible Party Barth Wilsey, University of California, Davis
Study Sponsor  ICMJE Barth Wilsey
Collaborators  ICMJE
  • VA Northern California Health Care System
  • University of California, San Diego
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Barth Wilsey, MD UC San Diego, Department of Psychiatry
PRS Account University of California, Davis
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP