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Multidisciplinary Association for Psychedelic Studies – MAPS

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Research

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 …
August 11, 2023

FDA Sends the Official Minutes of Type A Meeting for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On July 12, 2023, the FDA Division of Psychiatry sent MAPS the official minutes of our Type A meeting on June 15, 2023. The Type A meeting focused on the issues the FDA cited in its Clinical Hold on the …
July 12, 2023

FDA Grants In-Person Type A Meeting Request to Discuss Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

After reviewing MAPS’ Type A Meeting Request and Briefing submitted on April 28, the FDA granted MAPS’ meeting request. MAPS and the FDA will have a face-to-face formal meeting to discuss the …
May 9, 2023

MAPS Requests FDA for a Type A Meeting to Discuss Clinical Hold for the Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On April 28, 2023, MAPS requested the FDA for a Type A meeting to discuss the clinical hold issues for Study MJP2 in order to overcome the clinical hold deficiencies. This meeting request is in response …
April 28, 2023

Q4 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) #2

On March 14, 2023, MAPS released a progress report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Read the Q4 2022 progress report here.
March 14, 2023

FDA Provides Additional Guidance for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On January 19, 2023, the FDA advised MAPS that cannabis used in clinical trials is defined as a drug product, rather than a botanical raw material, for the purposes of microbiological testing acceptance …
January 19, 2023

FDA Continues Clinical Hold for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On December 16, 2022, the FDA advised MAPS that the Partial Clinical Hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) would be continued due to “insufficient information …
December 16, 2022

MAPS Submits Revised Protocol for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On November 16, 2022, MAPS submitted a revised protocol to the FDA in response to hold issues identified in the Agency’s Continued Partial Clinical Hold letters dated May 10 and December 27, 2021. …
November 16, 2022

October 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On October 15, 2022, MAPS released a progress report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Previous progress reports were released for quarters ending in January, April, and July. …
October 15, 2022

Response from FDA Regarding Request to Lift Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On August 30, 2022, the FDA responded to MAPS’ request to lift the clinical hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2), citing an incomplete response to the hold. …
August 30, 2022

Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) Continued Partial Clinical Hold Response

On August 16, 2022, MAPS submitted a complete response to the FDA addressing the continued partial clinical hold letter, received on December 27, 2021.
August 16, 2022

Statement on Clinical Treatment Practice using Cannabis to Treat Patients with Symptoms of Posttraumatic Stress Disorder (PTSD)

On July 21, 2022, a general medical and psychiatric practice in Steinheim, Germany, released a statement about their use of cannabis to treat patients with symptoms of posttraumatic stress disorder (PTSD). …
July 31, 2022

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Multidisciplinary Association for Psychedelic Studies – MAPS
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