On November 7, 2024, MAPS received notice from the FDA that the Phase 2 study of Cannabis for Veterans with PTSD (MJP2) is cleared to proceed with smoking as a delivery method. This update confirms that MAPS successfully cleared the prior clinical hold issues, removing important regulatory barriers to cannabis research modeled after real-world consumption patterns.
MAPS initially submitted the clinical study protocol for MJP2 on March 9, 2021, and the FDA placed the study on Clinical Hold on May 10, 2021. In the more than three years that followed, the FDA Division of Psychiatry Products (DPP) issued five Partial Clinical Hold letters repeatedly raising concerns about potential risks associated with the proposed dosing and administration of cannabis flower which were designed to model the real-world consumption of cannabis (see Study Timeline).
The FDA now indicated that they will allow the study to proceed with a self-titration dosing strategy via the inhalation of smoked dried cannabis flower with a THC-potency that corresponds to cannabis that is commercially available in states permitting legal medical and/or recreational adult use.
This achievement is the culmination of three years of negotiations which included six Complete Responses to the clinical hold, one Type A meeting with the Division of Psychiatry and Office of Neuroscience, and a final Formal Dispute Resolution Request which appealed DPP’s decision to the overseeing Office of Neuroscience. This accomplishment indicates that the FDA will allow cannabis research that models real-world consumption patterns among patient populations with serious conditions, like PTSD.
Despite this success, the letter from FDA was a “Continued Partial Clinical Hold” letter because the FDA requires more information regarding the mechanics and biological safety of the proposed vaporization device. MAPS successfully resolved the previous clinical issue where FDA asserted that “vaping is not a safe delivery mechanism.” While vaporization is now accepted as a delivery mechanism, FDA requires additional physical, mechanical, and safety information about the vaporization device itself prior to releasing the clinical hold on the use of the device in the protocol. MAPS successfully cleared the barriers to conducting a real-world study of smoked cannabis for the benefit of the cannabis research field and all those who seek to benefit from rigorous scientific research. MAPS will continue to provide additional information to FDA on the device to support the future integration of the vaporization option to the protocol to support participant choice of administration method.
MAPS is committed to advancing rigorous research on the clinical safety and utility of psychedelics, including cannabis. We strive to lay the groundwork and remove barriers to new or controversial research fields in part by setting regulatory precedents. The proposed Study MJP2 is intended to bolster the cannabis safety literature and contribute to a better understanding of the safety and effectiveness of real-world cannabis consumption by modeling commonly used routes of administration, dose, and high potency THC content.
Conducting research that reflects the already widespread use of inhaled cannabis is essential to ensuring that providers, consumers, and patients can make informed decisions about medical and recreational cannabis use. We believe that this three-year negotiation to permit this type of cannabis research will pave the way for other researchers to design similar studies that will lead to a new era of cannabis research.
Read the Continued Clinical Hold Letter here.