SCIENTISTS

Placebo

Bedrocan offers placebo versions of all of our strains for use in clinical studies. Each placebo contains the precise terpene profile of the original strain, with all cannabinoids removed to <0.2% of dry weight.

Full HPLC (high-performance liquid chromatography) and GC (gas chromatography) profiles are available on request. These profiles provide detailed information about cannabinoid and terpene content of all varieties.

Background

Modern clinical trials are typically performed as double-blinded, placebo-controlled studies. A placebo should ‘trick’ a subject into believing they are taking a real medicine, while in fact no active ingredient is present. In order to achieve this, the placebo should look, feel, taste and smell the same as the medicine under investigation. Indeed, no one should be able to distinguish between the real and the fake without chemical analysis.

Because most medicines come in the form of a pill without obvious taste or smell, the placebo pill simply needs to be of the same size and colour. A simple task! For cannabis, this is far more challenging. Cannabis has a typical smell and taste, especially when used in inhaled dose form (i.e. vaporized). Consequently, placebo cannabis must look like cannabis, but should also carry its taste and smell which is derived from the cannabis terpene content. For this reason, Bedrocan produces placebo cannabis by selectively removing the biologically active cannabinoids (like THC and CBD) while maintaining the original terpene content.

Fragrant terpenes

Terpenes are the constituents that give cannabis its typical smell and taste. Some of the more abundant terpenes include myrcene, pinene, humulene and terpineol. The presence of terpenes in our placebo make subjects believe they use ‘real’ cannabis, even when they receive no cannabinoids. Our products have been successfully used in several clinical trials (see references below).

Nonetheless, some terpenes may have a (mild) therapeutic effect on their own. This raises the question as to why terpenes are present in placebo cannabis. After all, a placebo is supposed to be therapeutically inactive. That is because without terpenes, a placebo would not smell or taste like the real medicine, and subjects would quickly guess they are not receiving real medicinal cannabis. This would unblind the study, with major effects on the study outcome. Also, the effect of the terpenes is considered to be minor compared to the much more potent cannabinoids.

Because we decide to add terpenes to our placebo, we have to make sure that their profile exactly matches that of the active cannabis used in the study. After all, if some terpenes do have a (mild) biological effect, the effect should be at least be the same for active and placebo cannabis. For this reason, each active Bedrocan cannabis variety comes with its own matching placebo.

How it is made

In order to turn active cannabis into placebo, we use solvent extraction to remove all cannabinoids. However, during this process we also remove all terpenes and moisture. In a subsequent step, removed terpenes and moisture are restored to their original levels. The final product is almost indistinguishable from the original cannabis it was made from.

At our facilities, operated under a GMP manufacturing licence issued by the Dutch Health Department, no toxic chemicals or solvents are used in the manufacturing process. All equipment is dedicated just for placebo production so that no cross-contamination can take place.

placebo-medicinal-cannabis-by-bedrocan-16

All placebo materials come with a full Certificate of Analysis. The following quality check tests are performed:

  • residual THC content (analysed by HPLC)
  • terpene profile (analysed by GC)
  • ethanol residue (analysed by GC)
  • water content (analysed by Loss on Drying)
  • particle size/appearance (evaluated by visual inspection)

Granulated flowers

The method we use to turn active cannabis into placebo uses homogenised cannabis as the starting material. We do this through a process called granulation, where the cannabis is broken up into smaller particles by pressing it through a metal screen with a pore size of approximately half a centimetre. For that reason, placebo material only comes in the form of granulate.

We do not deliver placebo in the form of whole flowers (known  as cannabis flos). When you wish to perform a study with our placebo, make sure you also order your active cannabis in granulated form. Granulation does not change the chemical composition or the therapeutic effects of cannabis. It only reduces the size of the dried flowers.

Shelf life and storage

In active cannabis, cannabinoids and terpenes are very stable for years when stored in the freezer (-20°C). At room temperature, the shelf life is 9-12 months in the original package (triple-laminated aluminium foil bags). We expect that the terpenes in placebo follow the same pattern. Actual shelf life data for placebo will be collected starting from 2017.

References

Our placebo materials have been successfully used in clinical trials. Here is a list of published papers so far:

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