MAPS’ proposed Study MJP2 study is a research study that is intended to add to the cannabis safety literature and contribute to a better understanding of the safety and effectiveness of real-world cannabis consumption modeling route of administration, dose, and % THC content. The study has been on Clinical Hold by FDA since May 10, 2021 due to FDA concerns about potential risks associated with the dosing and administration (see December 16, 2022 Clinical Hold Comments).
On November 30, 2023, MAPS submitted a Complete Response to FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). This response directly addresses the December 16, 2022 Clinical Hold Comments received from FDA, as well as taking into account the productive discussion that MAPS had with FDA in the Type A meeting on June 15, 2023 as well as the guidance and advice from the FDA Division of Pulmonology, Allergy, and Critical Care (DPACC), and a through review of the relevant literature.
In this response, MAPS argues that the risk of long-term effects on pulmonary and respiratory function in the proposed study population is low especially in light of the limited study duration, and notes the potential benefit of real-world data collection gained in this pioneering study. The MAPS submission is supported by letters from key opinion leaders in the field:
- Dr. Donald Tashkin, Distinguished Emeritus Professor of Medicine
Division of Pulmonary and Critical Care Medicine
University of California Los Angeles - Dr. Donald Abrams
Professor Emeritus of Medicine
University of California San Francisco - Dr. Igor Grant
Director Center for Medicinal Cannabis Research (CMCR)
Mary Gilman Marston, Distinguished Professor
University of California San Diego, Department of Psychiatry
MAPS anticipates a response from FDA to this request to remove the clinical hold from in 30 days.