NEGATIVE CONTROL CANNABIS FORMULATIONS
Compositions and methods useful for providing negative control formulations for clinical trials involving whole plant cannabis extracts are provided. The formulations include a plurality of odorants and flavorants designed to mimic the unique odor and flavor profile of whole plant cannabis extracts. The odorants and flavorants may include the terpenes and terpinoids.
1 . A composition comprising a plurality of flavorants in a suitable excipient/carrier such that the composition possesses the odor and flavor profile of cannabis and/or a cannabis extract, while being substantially free from cannabinoids.
2 . The composition of claim one wherein the odor/flavor profile is designed to match a particular strain of cannabis or extract therefrom.
3 . The composition of claim 1 wherein the plurality of flavorants comprise one or more compounds selected from the group consisting of the monoterpenes, diterpenes, carotenoids, phytols, tetraterpenes, sesquiterpenes, sterols, triterpenes, and flavonoids.
4 . A placebo comprising the composition of claim 1 .
5 . A method for providing negative control compositions for use in placebo controlled trials comprising the steps of formulating a composition having the odorant and flavor profile of a cannabis based therapeutic being tested in the same dosage form as the cannabis based therapeutic being tested.
6 . The method of claim 5 wherein the cannabis based therapeutic is a whole plant extract.
7 . A method for testing the hypothesis that one or more whole plant extracts are responsible for a particular biological effect or effects comprising:
selecting a whole plant extract to be tested for a particular biological effect or effects;
creating a negative control formulation that has a substantially similar odor/flavor profile of the whole plant extract while being substantially free of cannabinoids; and
running comparative tests between the whole plant extract and the negative control formulation.