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A case Study on the Challenges in Approvals for Cannabis Clinical Outcomes Research

Nicholas Toll
Florida Atlantic University

Co-authors: Ximena Levy1, Melanie Bone1
1Florida Atlantic University 

To describe the process and limitations a multidisciplinary team encountered in conducting a pilot study on the effects of Delta-8 THC in patients admitted to a memory care unit. Methods: The objective of the pilot study, funded by a private organization, was to explore the effects on vital signs, sleep patterns, and anxiety in patients admitted to a memory care unit authorized to offer cannabis-based therapies. The facility and healthcare providers are experienced in medical cannabis and collaborated with an academic institution to design and conduct the study. Patients were clinically eligible to receive Delta-8 THC as part of the standard of care; however, since the providers intended to collect data for research purposes, several layers of approvals were needed before the facility was allowed to provide the cannabis product and start the pilot study.

A research proposal, a clinical trial agreement (CTA), and IRB approval were required to be in place before starting the study. The initial step in the process was the signature of the CTA between the memory facility and the academic institution. Challenges related to liability, disposition of the cannabis product, limited knowledge, and regulations in the field required reprocessing the CTA once the initial agreement was signed. The IRB approval required several iterations of the protocol presented. The committee\’s limited experience in the review of proposals involving cannabis was one of the main challenges encountered. In addition, overlapping roles of the facility providers and the academic institution created additional delays in the process. The total time for approvals was eighteen months, resulting in the sponsor withdrawing the funding and the study being canceled.

Training, guidance, legal support, and standardized processes are required to advance the field of clinical research in medical cannabis. We are in urgent need of generating scientific evidence on the clinical effects of medical marijuana, but the limitations on the administration path to achieve the goal may be causing harm to populations using cannabis in a regular basis.

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