CompletedPhase 1Phase 2MS (type not specified)NCT01037088

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Mild dose cannabis
  • Low dose cannabis

Placebo or sham

  • Cannabis

Results by group

Participants With 30% or Greater Reduction in Pain Intensity

baseline to six hours

GroupValueIntervalNumber analysed
Mild Dose Cannabis61 percentage of participants45–7536
Low Dose Cannabis57 percentage of participants41–7137
Placebo Cannabis26 percentage of participants15–4238

Mild Dose Cannabis

61

Low Dose Cannabis

57

Placebo Cannabis

26

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Mild Dose Cannabis360 (0.0%)
Low Dose Cannabis370 (0.0%)
Placebo Cannabis380 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Participants With 30% or Greater Reduction in Pain Intensity

    baseline to six hours

    Pain

Other measures (1)

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

    baseline to six hours

    Pain

Who could take part

MS (type not specified) · 18 to 70

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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Related trials

History

    1. Started

      Dec 2009

    2. Main results due

      Nov 2012

    3. Finished

      Nov 2012

    4. Results posted

      Apr 2013

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