Phase 2 N=39 Randomized Triple-blind Treatment

Effects of Vaporized Marijuana on Neuropathic Pain

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

Bottom Line

View on ClinicalTrials.gov: NCT01037088 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2013

Primary outcome: Primary: Participants With 30% or Greater Reduction in Pain Intensity — 61; 57; 26 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mild dose cannabis (Drug); Low dose cannabis (Drug); Cannabis (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Davis
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With 30% or Greater Reduction in Pain Intensity	61; 57; 26	—
SECONDARY Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis	57.3; 54.4; 57.5; 51.8; 49.8; 56.5	>.05

Summary

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01037088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.