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
  Purpose

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


Condition Intervention Phase
Neuropathic Pain
Reflex Sympathetic Dystrophy
Peripheral Neuropathy
Post-herpetic Neuralgia
Spinal Cord Injury
Multiple Sclerosis
Drug: Cannabis
Phase 1
Phase 2

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: CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: December 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild dose cannabis
3.53% THC by weight
Drug: Cannabis
3.53% THC by weight
Other Name: marijuana
Experimental: Low dose cannabis
1.29% THC by weight
Drug: Cannabis
1.29% THC by weight
Other Name: marijuana
Placebo Comparator: Placebo cannabis
placebo marijuana
Drug: Cannabis
0.00% THC by weight
Other Name: placebo marijuana

  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
  • 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.
  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: NCT01037088

Locations
United States, California
CTSC Clinical Research Center, Sacramento VA Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Investigators
Principal Investigator: Barth L Wilsey, MD University of California, Davis
  More Information

Additional Information:
Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01037088     History of Changes
Other Study ID Numbers: 200614658, C06-DA-119
Study First Received: December 17, 2009
Results First Received: December 6, 2012
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
cannabis
marijuana
neuropathy
antinociception
mood
cognition
neuropathic pain

Additional relevant MeSH terms:
Multiple Sclerosis
Neuralgia
Peripheral Nervous System Diseases
Neuralgia, Postherpetic
Reflex Sympathetic Dystrophy
Sclerosis
Spinal Cord Injuries
Wounds and Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 26, 2014