Does PCORI consider cannabis a "novel" pharmacologic intervention?

The question of whether cannabis can be effectively used as an intervention for the prevention of migraine is an important one. However, for both methodological and practical considerations, PCORI has not included research specifically on the comparative effectiveness of cannabis among our priority research topics at this time. While the access to cannabis has been legalized in selected state jurisdictions and is being utilized in selected clinical circumstances, federal statutes on prohibition of its use remain in place. More importantly, FDA does not consider dry cannabis leaves to be approved 'therapeutics' except where other therapeutic agents have been developed from its active ingredient.

 

From a methodological standpoint, there is not a clear standard in how to assess dosing, purity of unprocessed cannabis, and/or what might be different levels of treatment regiments, each of which presents significant challenges in rigorously assessing the use of cannabis in the context of this funding opportunity. PCORI research in comparative effectiveness focuses on interventions generally of known efficacy or commonly in use in clinical or healthcare context, and that can be implemented broadly. As such, we are not able to clearly define unprocessed cannabis as a therapeutic to be studied in comparative effectiveness research context in general. For the purpose of this funding opportunity, we do not consider a study of medical cannabis to be responsive.