Title:Chronic Cannabis Users: A New Special Population to Consider for Drug
Development
Volume: 17
Issue: 1
Author(s): Gina Pastino*Diana Shuster
Affiliation:
- Department of Scientific Affairs, Clinical Pharmacology, PRA Health Sciences, Blue Bell, Pennsylvania, United States
Keywords:
Cannabis, marijuana, clinical pharmacology, delta-9-tetrahydrocannabinol, cannabidiol, special population.
Abstract: The use and acceptance of cannabis, either medically or recreationally, has substantially
outpaced the collection of data necessary to evaluate it’s use in any population. However, the mere
widespread availability does not imply the absence of risk or confirmation of efficacy and should not
be treated as such. There is enough data to suggest that not only does the potential for pharmacokinetic
and metabolic interactions exist, but also that baseline characteristics for a given population could be
different in chronic cannabis users. Either or both of these may impact the safety and efficacy profile
for any new drug in development. As such, we encourage drug developers to consider that the cannabis
user may very well be a special population that warrants its own clinical pharmacology evaluation.