We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Vaporized Marijuana on Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Reflex Sympathetic Dystrophy Peripheral Neuropathy Post-herpetic Neuralgia Spinal Cord Injury Multiple Sclerosis Drug: Mild dose cannabis Drug: Low dose cannabis Drug: Cannabis Phase 1 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain
Study Start Date : December 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Mild dose cannabis
3.53% THC by weight
 Drug: Mild dose cannabis
3.53% THC by weight
Other Name: marijuana
Experimental: Low dose cannabis
1.29% THC by weight
 Drug: Low dose 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037088


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Barth L Wilsey, MD University of California, Davis
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01037088    
Other Study ID Numbers: 200614658
C06-DA-119 ( Other Grant/Funding Number: Center for Medicinal Cannabis Research )
First Posted: December 21, 2009    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: January 31, 2018
Last Verified: October 2017
Keywords provided by University of California, Davis:
cannabis
marijuana
neuropathy
antinociception
 mood
cognition
neuropathic pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Spinal Cord Injuries
Neuralgia
Peripheral Nervous System Diseases
Neuralgia, Postherpetic
Reflex Sympathetic Dystrophy
Complex Regional Pain Syndromes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neuromuscular Diseases
Pain
Neurologic Manifestations
Autonomic Nervous System Diseases