INVESTIGATOR: Nathaniel Schuster, Ph.D.
STUDY LOCATION: University of California, San Diego
PROJECT TITLE: Vaporized cannabis flower for the acute treatment of migraine: a randomized, double-blind, placebo-controlled trial with open-label extension
FUNDING SOURCE: Center for Medicinal Cannabis Research
PROJECT TYPE: Clinical Study
STATUS: Active
ABSTRACT:
Background/Significance: Society needs rigorous evidence regarding the medical use of cannabis for migraine, given that 35.5% of medical cannabis users report using cannabis to treat headache. Our phase 2, placebo-controlled crossover trial demonstrated that 6% THC/11% CBD was superior to placebo for all primary and key secondary endpoints. However, an evidence gap is that the efficacy of cannabis for acute migraine has not been demonstrated in a parallel-group trial, and consistency of response across multiple treated attacks has not been tested. The proposed study will fill this evidence gap and provide level 1 evidence for cannabis for acute migraine.
Hypothesis: 6% THC/11% CBD cannabis flower will be superior to placebo cannabis for aborting acute migraine attacks without significant adverse events and with consistent responses across 4 open-label treated attacks. Innovation: Providing level 1 evidence for the first available inhaled treatment for acute migraine.
Design-Methods: Adults ages 21-65 experiencing 2-23 headache and migraine days per month will be randomized in a double-blind, 1:1 manner to treat a single migraine attack with 6% THC/11% CBD versus placebo. This will be followed by an open-label extension in which all subjects will treat up to 4 migraine attacks with 6% THC/11% CBD, with at least 1 week washout period between each treated migraine attack. They will have up to 1 year to treat all migraine attacks. Statistical Plan of Analysis: Preliminary analyses will begin with an examination of the distribution of variables to assess and describe their characteristics (means, medians, standard deviations, quartiles, ranges, frequencies and percentages) for overall and by study group. Randomization will be assessed by performing a series of Wilcoxon rank-sum test for continuous variables and Chi-square (or Fisher’s exact) tests for categorical variables to compare the groups on demographic and initial clinical variables. Variables on which the groups differ initially will be explored as covariates in subsequent analyses. Intent-to-treat analysis will be conducted as a primary analysis. A secondary analysis will be performed for those who reported the outcome at 2 hours (-30/+60 mins). Analyzes will be conducted using open source statistical software R.
Implications: Following a second randomized, double-blind, placebo-controlled trial we anticipate that 6% THC/11% CBD will be included in acute migraine treatment guidelines.