Effects of Vaporized Marijuana on Neuropathic Pain

Multiple Sclerosis Clinical Trial

Official title:

CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037088
• Other study ID #: 200614658
• Secondary ID: C06-DA-119
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 17, 2009
• Last updated: January 11, 2018
• Start date: December 2009
• Est. completion date: November 2012

Study information

• Verified date: October 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Multiple Sclerosis
• Neuralgia
• Neuralgia, Postherpetic
• Neuropathic Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Post-herpetic Neuralgia
• Reflex Sympathetic Dystrophy
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Mild dose cannabis
3.53% THC by weight
• Low dose cannabis
1.29% THC by weight
• Cannabis
0.00% THC by weight

Locations

Country	Name	City	State
United States	CTSC Clinical Research Center, Sacramento VA Medical Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Center for Medicinal Cannabis Research, VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Center for Medicinal Cannabis Research website