The FDA has placed a partial clinical hold on MAPS’ investigational study (IND 110513) involving inhaled cannabis for veterans with PTSD. The agency cites insufficient data to assess the risks associated with the study’s proposed THC concentrations, which are higher than those used in previous trials. The study’s flexible dosing, varied administration methods (smoking vs. vaping), and potential for high THC exposure raise concerns about safety. The FDA requires MAPS to submit additional data proving that the proposed THC doses are safe and well-tolerated before the study can proceed. Until the agency receives and reviews this information, the study may not legally begin.
Beyond the clinical hold, the FDA also provides recommendations to improve study design and safety monitoring. These include using a fixed-dose approach to ensure consistency in THC exposure, broadening participant eligibility beyond veterans, and implementing enhanced safety assessments such as ECG monitoring and additional lab tests. The agency also advises MAPS to clarify statistical methods for handling missing data and interim analyses.
To read the FDA’s full letter click here.