Effects of Vaporized Marijuana on Neuropathic Pain
Primary Purpose
Neuropathic Pain, Reflex Sympathetic Dystrophy, Peripheral Neuropathy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mild dose cannabis
Low dose cannabis
Cannabis
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring cannabis, marijuana, neuropathy, antinociception, mood, cognition, neuropathic pain
Eligibility 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.
Sites / Locations
- CTSC Clinical Research Center, Sacramento VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Mild dose cannabis
Low dose cannabis
Placebo cannabis
Arm Description
3.53% THC by weight
1.29% THC by weight
placebo marijuana
Outcomes
Primary Outcome Measures
Participants With 30% or Greater Reduction in Pain Intensity
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
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis
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).
Full Information
NCT ID
NCT01037088
First Posted
December 17, 2009
Last Updated
January 11, 2018
Sponsor
University of California, Davis
Collaborators
Center for Medicinal Cannabis Research, VA Northern California Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT01037088
Brief Title
Effects of Vaporized Marijuana on Neuropathic Pain
Official Title
CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Center for Medicinal Cannabis Research, VA Northern California Health Care System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Reflex Sympathetic Dystrophy, Peripheral Neuropathy, Post-herpetic Neuralgia, Spinal Cord Injury, Multiple Sclerosis
Keywords
cannabis, marijuana, neuropathy, antinociception, mood, cognition, neuropathic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild dose cannabis
Arm Type
Experimental
Arm Description
3.53% THC by weight
Arm Title
Low dose cannabis
Arm Type
Experimental
Arm Description
1.29% THC by weight
Arm Title
Placebo cannabis
Arm Type
Placebo Comparator
Arm Description
placebo marijuana
Intervention Type
Drug
Intervention Name(s)
Mild dose cannabis
Other Intervention Name(s)
marijuana
Intervention Description
3.53% THC by weight
Intervention Type
Drug
Intervention Name(s)
Low dose cannabis
Other Intervention Name(s)
marijuana
Intervention Description
1.29% THC by weight
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
placebo marijuana
Intervention Description
0.00% THC by weight
Primary Outcome Measure Information:
Title
Participants With 30% or Greater Reduction in Pain Intensity
Description
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.
Time Frame
baseline to six hours
Secondary Outcome Measure Information:
Title
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis
Description
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).
Time Frame
baseline to six hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barth L Wilsey, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
CTSC Clinical Research Center, Sacramento VA Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18403272
Citation
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.
Results Reference
background
Links:
URL
http://www.cmcr.ucsd.edu/
Description
Center for Medicinal Cannabis Research website
Learn more about this trial
Effects of Vaporized Marijuana on Neuropathic Pain
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