December 8, 2018
The National Center for Complementary and Integrative Health (NCCIH) supports rigorous scientific investigation of natural products such as the cannabis plant and its components (e.g., cannabinoids and terpenes). The following funding opportunities could be used to support meritorious cannabinoid-related research. Funded projects must follow all Federal laws related to cannabis, including getting a determination from the Drug Enforcement Administration about whether site registration is necessary (all studies) and finding out whether the Food and Drug Administration will require an Investigational New Drug submission (human studies). For an updated list of all NCCIH funding opportunities, visit nccih.nih.gov/grants/funding.
Exploring the Mechanisms Underlying Analgesic Properties of Minor Cannabinoids and Terpenes (R01, R21; NOT-AT-19-008 and NOT-AT-19-009). NCCIH has issued Notices of Intent to publish Funding Opportunity Announcements (FOAs) to support research on minor cannabinoids and terpenes from the cannabis plant related to pain and nociception. For these FOAs, minor cannabinoids are defined as any and all cannabinoids from the cannabis plant other than ∆9-tetrahydrocannabinol (∆9-THC). This initiative will support basic and/or mechanistic studies in model organisms and/or human subjects aiming to identify, describe, and predict if minor cannabinoids and/or terpenes can help treat pain. The FOAs are expected to be published in January 2019 with an expected application due date in March 2019. NCCIH intends to commit up to $3 million to this effort in FY 2019.
Natural Product Early Phase Clinical Trial – Determining and Replicating Biological Signature (R61/R33, R33; PAR-18-829 and PAR-18-828). These FOAs support early phase clinical trials of natural products and the development/characterization of their biological signatures (objective measures of a natural product’s effects). The establishment of a biological signature is important to maximize the impact of natural product clinical trials. Biological signatures may be an objective single measure, proxy, correlate, or combination of molecular/cellular, psychological, neural circuit, tissue/organ, and/or somatic changes. The R61/R33 should be used to measure the impact of the natural product on a biological signature (R61 phase), replicate the impact on and determine the reproducibility of the biological signature in a separate study (R33 phase), determine the bioavailability and pharmacokinetics of the natural product, and possibly determine the dose that optimizes its impact (R33 phase).
Natural Product Phase II Clinical Trial Cooperative Agreement Award (U01; PAR-18-125). This FOA is intended to build on early phase biological signature work and generate the preliminary data needed to inform the design of a fully powered multisite efficacy trial. The U01 clinical trial FOA will support natural product clinical trials (Phase II), such as dosing and formulation optimization of the natural product, to be used in a future multisite randomized clinical trial; collecting additional data documenting ability to recruit/accrue participants, achieve adherence to the study protocol, retain participants during a study, and complete collection of followup data; or determining which patient phenotypes will be likely responders versus nonresponders to the natural product to inform inclusion/exclusion criteria of a future multisite efficacy trial.
Multi-Site Investigator-Initiated Clinical Trials Cooperative Agreement Award (UG3/UH3, U24; PAR-18-696 and PAR-18-697). These FOAs support applications to implement a multisite clinical trial of a natural product (Phase III and beyond). Under a phased award, the UG3 phase supports the planning and development of resources necessary to perform the efficacy trial. If the UG3 phase successfully meets all planning milestones, the UH3 phase is awarded to implement the efficacy clinical trial. The UG3/UH3 award, therefore, is used to implement a Clinical Coordinating Center (CCC). In addition, multisite clinical trials require a companion Data Coordinating Center (DCC) application (U24) to be submitted with and linked to the CCC application. The two applications undergo peer review simultaneously. Multiple sites are necessary for efficacy trials to increase generalizability of findings and enhance recruitment efficiency as well as representativeness of the participants.