Clinical trial NCT01037088: Effects of Vaporized Marijuana on Neuropathic Pain
Official title: CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neuropathic Pain
Reflex Sympathetic Dystrophy
Peripheral Neuropathy
Post-herpetic Neuralgia
Spinal Cord Injury
Multiple Sclerosis
Keywords: cannabis
marijuana
neuropathy
antinociception
mood
cognition
neuropathic pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Center for Medicinal Cannabis Research
name: VA Northern California Health Care System
First posted: 2009-12-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Participants With 30% or Greater Reduction in Pain Intensity
timeFrame: baseline to six hours
Secondary outcomes:
measure: Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis
timeFrame: baseline to six hours
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: CTSC Clinical Research Center, Sacramento VA Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Barth L Wilsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.