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Currently, the state of California has the largest number of clinical studies in the country, making up more than 25% of registered clinical trials within the United States. Despite this, numerous studies that involve substances under Schedule I and II haven’t begun, even after obtaining clearance from the U.S. Drug Enforcement Administration (DEA), the U.S. Food and Drug Administration and institutional review boards.
This is mainly because of the Research Advisory Panel of California (RAP-C), established under state law as the California Research Advisory Panel back in 1965. The RAP-C encourages and coordinates further studies of psychedelics and marijuana. The panel also studies the effects and nature of hallucinogenic drugs or marijuana and holds hearings on research projects to be approved. This panel has the power to approve research projects or even withdraw that approval.
The RAP-C comprises of five members, including investigators with significant experience investigating scheduled drugs such as psychedelics. Current members include Jennifer Mitchell and Boris Heifets. The cause of slow advancement in psychedelic research in California is due to the panel’s apparent inability to meet. The final meetings of the 2023 calendar year, scheduled for October and December, were cancelled. This meant that applications submitted up to Sept. 1, 2023, remained in bureaucratic limbo.
The panel only meets six times annually, which increases backlog if proposals aren’t approved within the stipulated windows.
The state’s AG says sponsors or researchers must tender their applications to RAP-C for any study projects that are to be carried out in California if any of the following reasons apply:
- Schedule I drug is administered in nonhuman research
- A Schedule I or II drug is the primary study substance or a comparison substance/drug for studies involving human subjects
- Any study on the treatment of controlled substance use disorder uses any non-scheduled or scheduled drug
It is important to keep in mind that sponsors can only present their planned studies to the board after receiving all other required approvals, such as those from the FDA and DEA as well as safety monitoring boards and institutional review boards.
Once a research plan is submitted, RAP-C may reject, approve or suggest amendments. In 2022, the panel reviewed more than 50 study applications. Of the total number, 3 didn’t receive approval or were withdrawn, 36 obtained approval and 15 were pending finalization as of Dec. 31, 2022.
An analysis determined that almost 40% of those 36 approved research projects focused on researching psychedelics. They include UC San Francisco’s comparison study of sublingual and oral psilocin using Filament Health’s formulations; Mind Medicine Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ)’s phase 2 trials on the use of LSD in treating anxiety symptoms; and Compass Pathways’ proof-of-concept study on psilocybin therapy in anorexia nervosa.
According to RAP-C’s 2022 annual report, ongoing studies also include research on MDMA-assisted psychotherapy for post-traumatic stress disorder; psilocybin for anxiety and depression among Parkinson’s disease patients; and psilocybin therapy for chronic lower back and phantom limb pain, among others.
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