Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation
Status:
Not yet recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be
an effective treatment for psychotic disorders, anxiety disorders and addictions. It is
available as an oral liquid and as standard oral capsules.
The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly
in the fasted state. With food, its absorption is much higher. In one study, a high-fat
breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food
effect, when prescribing standard oral formulations of CBD, clinicians should provide advice
on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side
effects or limited effectiveness.
One way to reduce the food effect and improve bioavailability is to use lipid encapsulation.
In the present study, the investigators will evaluate CBD at the dose that is effective in
patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all
EU pharmacopoeia approved and have been used in medicinal products before.
The study aims to assess whether a novel lipid formulation can increase the bioavailability
of oral CBD in the fasting state.