Research
MAPS Successfully Clears Path for Cannabis Research through FDA Formal Dispute
FOR IMMEDIATE RELEASE: November 20, 2024 The U.S. Food and Drug Administration (FDA) Division of Psychiatry Products has cleared the Multidisciplinary Association for Psychedelic Studies (MAPS)’ Phase …
MAPS cleared to proceed by FDA on Phase 2 Study of Smoked Cannabis for Veterans with PTSD (MJP2)
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 submits sixth Clinical Hold Response to FDA on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
On October 10, 2024, MAPS submitted a Complete Response to FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). This response addressed the four key clinical hold issues identified …
MAPS achieves agreement on three key points despite “Appeal Denied” letter received from FDA on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
On September 19, 2024, MAPS received the response from the Office of Neuroscience to the Formal Dispute Resolution Request (FDRR) submitted by MAPS on August 23, 2024. The FDRR was submitted in response …
MAPS Awards Grant for Pilot MDMA-assisted Massed Exposure Therapy Trial
FOR IMMEDIATE RELEASE: August 27, 2024 The Multidisciplinary Association for Psychedelic Studies (MAPS) awarded Emory University researchers a $200,000 grant for a pilot study examining MDMA-assisted Massed …
MAPS Submits Formal Dispute Resolution Request Against FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
On August 23, 2024, MAPS submitted a Formal Dispute Resolution Request to appeal the Clinical Hold placed on the Phase 2 study of cannabis for Veterans with PTSD (MJP2) by the FDA Division of Psychiatry …
MAPS Statement on FDA Complete Response Letter on MDMA-Assisted Therapy for PTSD New Drug Application
FOR IMMEDIATE RELEASE: August 9, 2024 Aug 9, 2024 – San Jose, CA – The Multidisciplinary Association for Psychedelic Studies (MAPS) is evaluating the path forward for safe, legal access to MDMA-assisted …
MAPS Submits Cannabis Data Safety Update Report 2023 to FDA on Phase 2 Study of Smoked Cannabis for Veterans with PTSD (MJP2)
On January 11, 2024, MAPS submitted to the FDA the 2023 Cannabis Data Safety Update Report (DSUR). The DSUR serves as the FDA Annual Report on the progress of the drug investigation over the last year. …
FDA Continues Clinical Hold for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
On December 28, 2023, the FDA Informed MAPS that the Partial Clinical Hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) would be continued. This Clinical Hold letter rejects the …
MAPS Submits Complete Response to FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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 …
FDA Division of Pulmonology, Allergy, and Critical Care Provides Additional Guidance on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
On August 11, the FDA Division of Pulmonology, Allergy, and Critical Care (DPACC) sent MAPS additional guidance on the safety of smoking in naïve subjects in MJP2. The FDA’s correspondence was a …