Effects of Vaporized Marijuana on Neuropathic Pain

University of California, Davis44 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

Mild dose cannabisDRUG

3.53% THC by weight

Low dose cannabisDRUG

1.29% THC by weight

CannabisDRUG

0.00% THC by weight

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

CTSC Clinical Research Center, Sacramento VA Medical Center

Sacramento, California, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline to six hours

Secondary Outcomes

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).

Time frame: baseline to six hours

Data from ClinicalTrials.gov

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