Effects of Vaporized Marijuana on Neuropathic Pain

This study has been completed.
Sponsor:
Collaborators:
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01037088
First received: December 17, 2009
Last updated: April 5, 2013
Last verified: April 2013

December 17, 2009
April 5, 2013
December 2009
November 2012   (final data collection date for primary outcome measure)
Participants With 30% or Greater Reduction in Pain Intensity [ Time Frame: baseline to six hours ] [ Designated as safety issue: No ]
The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.
Score on a series of pain scales (heat pain threshold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01037088 on ClinicalTrials.gov Archive Site
Not Provided
  • Number of subjects who are unable to tolerate the high dose without significant side effects. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Changes in mood, cognitive impairment, and psychomotor performance (mood - VAS happiness, cognition - Digit Symbol Modalities Test, psychomotor performance - Grooved Pegboard Test). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Vaporized Marijuana on Neuropathic Pain
CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain

This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neuropathic Pain
  • Reflex Sympathetic Dystrophy
  • Peripheral Neuropathy
  • Post-herpetic Neuralgia
  • Spinal Cord Injury
  • Multiple Sclerosis
  • Drug: Cannabis
    3.53% THC by weight
    Other Name: marijuana
  • Drug: Cannabis
    1.29% THC by weight
    Other Name: marijuana
  • Drug: Cannabis
    0.00% THC by weight
    Other Name: placebo marijuana
  • Experimental: Mild dose cannabis
    3.53% THC by weight
    Intervention: Drug: Cannabis
  • Experimental: Low dose cannabis
    1.29% THC by weight
    Intervention: Drug: Cannabis
  • Placebo Comparator: Placebo cannabis
    placebo marijuana
    Intervention: Drug: Cannabis
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. Epub 2008 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than 18 and less than 70
  • Visual Analogue Scale (VAS pain intensity) greater than 3/10
  • A negative urine drug screening test, i.e., no evidence of IV drug abuse
  • Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Exclusion Criteria:

  • Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
  • Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
  • Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
  • History of traumatic brain injury
  • Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
  • Current use of marijuana (e.g., within 30 days of randomization)
  • Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01037088
200614658, C06-DA-119
No
University of California, Davis
University of California, Davis
  • Center for Medicinal Cannabis Research
  • VA Northern California Health Care System
Principal Investigator: Barth L Wilsey, MD University of California, Davis
University of California, Davis
April 2013

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