People have used marijuana, also called cannabis, for health purposes for thousands of years. Recent growing interest on the part of health-care providers and the public has been pointing toward use of cannabis and its components to treat medical conditions. A number of states and the District of Columbia have legislation allowing specific uses for medical purposes. At the same time, cannabis is Federally regulated as a Schedule I controlled substance. This situation presents unique obstacles for conducting basic and clinical research and for medication development. While research can be done, the landscape is complex and challenging.
To help provide a path forward for addressing regulatory challenges in conducting research, NCCIH sponsored a workshop in December 2018 on “Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework.” We have just published the summary. The experts who presented at the workshop and reviewed its summary included researchers, government officials (from NCCIH, other NIH institutes, the Food and Drug Administration (FDA), and the Drug Enforcement Administration), and industry representatives. They discussed topics such as the state of the science on the risks and potential benefits of cannabis; the regulatory landscape; the FDA approval process; and how to advance the research, including toward FDA-approved product development for clinical use.
At the workshop, participants acknowledged that the marketing and use of cannabis is running way ahead of the evidence. Because of that, health care providers face a dilemma of sharing recommendations with patients about cannabis when there is a dearth of evidence, publications, and/or high-quality studies. Also, the risk of adverse outcomes increases with self-administration of products that have few requirements for standardization or quality control.
As I have blogged before, NCCIH supports studies on cannabinoids within the existing regulatory framework to expand the evidence base on their efficacy and safety. We see possible therapeutic benefit in some of the 80-plus phytocannabinoids and terpenes found in the cannabis plant. NCCIH has issued several funding opportunity announcements (FOAs) highlighting our interests, including:
- For mechanistic research on minor cannabinoids and terpenes from the cannabis plant in relation to pain and nociception (RFA-AT-19-008 and RFA-AT-19-009, which had a receipt date of March 16, 2019)
- To support early-phase clinical trials of natural products and the development/characterization of their biological signaturesthe objective measures of a natural product’s effects (PAR-18-129 and PAR-18-128, still-active FOAs with fall 2019 receipt dates)
- PA-18-917, to support projects examining the therapeutic potential of cannabinoids and the endocannabinoid system across a variety of pain conditions (an FOA co-sponsored by NCCIH with five other NIH components and with standard due dates).
NCCIH is committed to requiring product integrity in studies of cannabis and other natural products. Our Product Integrity Policy helps raise investigators’ and the Center’s confidence that an NCCIH-funded study will have definitive, reproducible results.
It was evident at the workshop that this field of research holds exciting potential. NCCIH shares the widespread hope of finding effective, safe options to control pain and address other difficult medical problems, including through rigorous studies on natural products such as cannabis.
- View summary of “Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework”