On January 15, 2025, MAPS submitted to the FDA the 2024 Cannabis Data Safety Update Report (DSUR) along with a protocol amendment. The DSUR serves as the FDA Annual Report on the progress of the drug investigation over the last year. Very few updates were made to the DSUR this year, given that Study MJP2 remained on clinical hold until November 7, 2024 when it was cleared to proceed with smoking as the only administration method for ingesting study product.
MAPS also submitted a protocol amendment and informed consent form (ICF) amendment. Most notably, the protocol and ICF amendments removed the vaporization of cannabis flower as an optional method of administration to align the protocol with FDA’s clearance of smoking only as the administration method.
In the Continued Clinical Hold letter received by the FDA on November 7, 2024, the FDA agreed that both smoking and vaporization of cannabis flower were acceptable administration methods that do not pose an unreasonable risk for the PTSD patient population. However, the 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.
While MAPS plans to provide the FDA with additional information on the device to support the future integration of the vaporization option into the protocol, MAPS submitted updated protocol and ICF amendments removing this option so that clinical sites have a clear protocol for study start-up. MAPS hopes to clear the vaporization administration option with the FDA prior to initiating recruitment to support participant choice of administration method.
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 adult cannabis use. MAPS remains committed to paving the way for novel cannabis and psychedelic research.
Read the Cannabis Data Safety Update Report 2024 here.
Read the Protocol Amendment A3V1 here and the Informed Consent Form V3 here.