Cannabis products have been used for a very long time and their effects, some therapeutic, well documented. Despite all of this, we still lack solid clinical evidence to support its numerous therapeutic uses. While most cannabis trials performed to date focused on its safety, well-designed placebo-controlled clinical trials must be done to prove its efficacy in each of these indications. Cannabis clinical trials pose a different set of challenges that should be considered prior to initiating a clinical program. With a controlled-substance classification in most countries, access to medicinal grade cannabis is not simple, even for clinical trials. Current regulations, which vary greatly from one country to the other, not only impact access to cannabis products, but also its packaging and distribution. Each new formulation brings a special set of considerations that can affect the trial design, type of placebo, packaging and patient administration. This talk will review the particularities of cannabis clinical trials and how these different challenges can be overcome.