Cannabis in Acute Migraine Treatment Project
This group of researchers, with the aid of a $3,500 grant from MAPS, has submitted a research proposal to the National Institutes of Health (NIH). The study was approved by the St. Patrick Hospital / Community Medical Center Joint Investigational Review Board, whose ruling was also accepted by the IRB of the University of Montana.
Cannabis, or marijuana, has been used for centuries for both symptomatic and prophylactic treatment of migraine. It was part of the Western pharmacopoeia for this indication even into the mid-twentieth century. Current anecdotal studies continue to refer to its efficacy for this malady, while biochemical studies of THC and anandamide have provided a scientific basis for such treatment.
Thirty patients meeting International Headache Society (IHS) criteria of acute migraine with or without aura, and in whom treatment with subcutaneous sumatriptan has been ineffective or poorly tolerated, will be recruited. Exclusion criteria will include concomitant use of MAO inhibitor drugs, pregnancy, cardiac conditions, history of drug or analgesic dependency.
After suitable informed consent, study patients will be randomized to receive study medications consisting of meperidine 1 mg./kg. I.M. along with hydroxyzine 50 mg. as an anti-emetic, or Marinol (dronabinol, synthetic THC) 10 mg. p.o., or an oral placebo capsule (Vitamin E), or alternatively, one or more inhalations of pre-sterilized, pyrolysed Cannabis, employing marijuana cigarettes with a standardized 4% THC content. The pyrolysed Cannabis dose will be titrated to the patients' responses. All patents will be monitored for one hour, at which time a preliminary questionnaire regarding symptom relief, and a Folstein Mini-Mental State Examination will be performed. Blood samples for THC will be drawn at one and two hours in the dronabinol and placebo caps ule groups and, and at ten minutes and one hour in the marijuana-treated patients. Folstein tests will be repeated at the two-hour mark. Patients will then be allowed to return home, with a designated driver, or via arranged transportation.
All patients will subsequently complete questionnaires at the four-hour, and twenty-four hour marks employing visual analog scales to determine efficacy of their treatment with respect to pain levels, nausea and photophobia, and their perceived ability to engage in work or study activities.
The proposed budget for this study is $145,500. After the review by a NIDA study section, the results of which will be known in November 1997, there are three possible outcomes. The study may be rejected outright, approved but not funded, or approved and funded. Should it be accepted, but not funded, the possibility remains that it could be completed through private funding sources.
Questions may be directed to:
Ethan Russo, M.D.