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Effects of Vaporized Marijuana on Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01037088
Recruitment Status : Completed
First Posted : December 21, 2009
Results First Posted : April 9, 2013
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE December 17, 2009
First Posted Date  ICMJE December 21, 2009
Results First Submitted Date  ICMJE December 6, 2012
Results First Posted Date  ICMJE April 9, 2013
Last Update Posted Date January 31, 2018
Study Start Date  ICMJE December 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
Participants With 30% or Greater Reduction in Pain Intensity [ Time Frame: baseline to six hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
Score on a series of pain scales (heat pain threshold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale). [ Time Frame: 1 month ]
Change History Complete list of historical versions of study NCT01037088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis [ Time Frame: baseline to six hours ]
The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
  • Number of subjects who are unable to tolerate the high dose without significant side effects. [ Time Frame: 1 month ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Vaporized Marijuana on Neuropathic Pain
Official Title  ICMJE CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain
Brief Summary This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.
Detailed Description We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pain
  • Reflex Sympathetic Dystrophy
  • Peripheral Neuropathy
  • Post-herpetic Neuralgia
  • Spinal Cord Injury
  • Multiple Sclerosis
Intervention  ICMJE
  • Drug: Mild dose cannabis
    3.53% THC by weight
    Other Name: marijuana
  • Drug: Low dose cannabis
    1.29% THC by weight
    Other Name: marijuana
  • Drug: Cannabis
    0.00% THC by weight
    Other Name: placebo marijuana
Study Arms  ICMJE
  • Experimental: Mild dose cannabis
    3.53% THC by weight
    Intervention: Drug: Mild dose cannabis
  • Experimental: Low dose cannabis
    1.29% THC by weight
    Intervention: Drug: Low dose cannabis
  • Placebo Comparator: Placebo cannabis
    placebo marijuana
    Intervention: Drug: Cannabis
Publications * 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. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.

*   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: December 18, 2009)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT01037088
Other Study ID Numbers  ICMJE 200614658
C06-DA-119 ( Other Grant/Funding Number: Center for Medicinal Cannabis Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE
  • Center for Medicinal Cannabis Research
  • VA Northern California Health Care System
Investigators  ICMJE
Principal Investigator: Barth L Wilsey, MD University of California, Davis
PRS Account University of California, Davis
Verification Date October 2017

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