Effects of Vaporized Marijuana on Neuropathic Pain

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

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis, Neuropathic Pain, Reflex Sympathetic Dystrophy, Peripheral Neuropathy, Post-herpetic Neuralgia, Spinal Cord Injury

Intervention / Treatment
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* Drug: Mild dose cannabis
* Drug: Low dose cannabis
* Drug: Cannabis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild dose cannabis<br>3.53% THC by weight | Drug: Mild dose cannabis<br>* 3.53% THC by weight<br>* Other names: marijuana;|
| Experimental: Low dose cannabis<br>1.29% THC by weight | Drug: Low dose cannabis<br>* 1.29% THC by weight<br>* Other names: marijuana;|
| Placebo Comparator: Placebo cannabis<br>placebo marijuana | Drug: Cannabis<br>* 0.00% THC by weight<br>* Other names: placebo marijuana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline to six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | baseline to six hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cannabis, marijuana, neuropathy, antinociception, mood, cognition, neuropathic pain