Cannabis in Migraine Treatment Study
(updated February 20, 2000)
On December 6, 1999, Dr. Ethan Russo, U. Montana, heard that NIDA's special review committee convened in November 1999 rejected his MAPS-supported, IRB-and FDA-approved protocol. He was informed that he will not be permitted to purchase marijuana from NIDA for his study. In February 2000 Russo received a letter from NIDA with a Summary Statement explaining the reasons for the review committee's rejection. The protocol was approved by the FDA in September 1999.
A press release was prepared by the Marijuana Policy Project, which has been lobbying against the new HHS guidelines for medical marijuana research which permit NIDA to create its own special review committee to review protocols that have already been approved by FDA and Institutional Review Boards. All that Dr. Russo and MAPS have been seeking is the ability to purchase low quality marijuana from NIDA at a price that has not yet been made public. The sad truth is that NIDA is still successfully blocking medical marijuana research.
We are currently reassessing how to proceed with efforts to conduct privately funded medical marijuana research. NIDA's monopoly control over the supply of marijuana that can be used in FDA-approved research projects highlights the important of MAPS' long-term effort to obtain permission from DEA to establish an independent facility to produce marijuana for FDA-approved research.
While Dr. Russo is seeking to study cannabis in the treatment of migraines, he has discussed patient reports and biological studies that suggest a variety of psychedelics could also be helpful to patients with migraines and cluster headaches. Read commentary
About this protocol
In the Spring of 1997, with the aid of a $3,500 grant from MAPS, Dr. Ethan Russo submitted a research proposal to the National Institutes of Health (NIH). The design of this study was for 30 patients meeting criteria of acute migraine with or without aura, and in whom treatment with subcutaneous sumatriptan has been ineffective or poorly tolerated.
NIH Rejects First Application for Cannabis in Migraine Treatment Study
Second Application Denied
The formal NIH critique of this second application was prepared in January 1999. The reviewers focused in large part on an issue that cannot be resolved and that has nothing to do with the scientific merit of the protocol design, the supposed need for preliminary data to supplement extensive historical and anecdotal reports. Dr. Russo's response to the critique describes why he initially decided to not attempt a third application to the NIH to study cannabis for migraine.
Migraine Protocol Finally Critiqued by FDA
Cannabis in Migraine Treatment Project Close to FDA Approval
FDA Approves Investigational IND for Cannabis in Migraine