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OpenTrials
Completed

NCT Number: NCT01037088

Effects of Vaporized Marijuana on Neuropathic Pain

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mild dose cannabis

Drug

3.53% THC by weight

Other names: marijuana

Low dose cannabis

Drug

1.29% THC by weight

Other names: marijuana

Cannabis

Drug

0.00% THC by weight

Other names: placebo marijuana

Primary outcomes

  1. Participants With 30% or Greater Reduction in Pain Intensity

    Time frame: baseline to six hours

    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.

Secondary outcomes

  1. Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis

    Time frame: baseline to six hours

    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).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Center for Medicinal Cannabis Research
  • VA Northern California Health Care System

Registry information

Official study title

CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2009
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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