Q4 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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.
Research
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 …
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 …
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. …
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. …
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. …
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.
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 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
On July 15, 2022, MAPS released a grant progress report for our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Previous grant reports were released in January and April. Read the July 2022 grant …
Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) Regulatory Correspondences with FDA
Study MJP2 protocol was initially submitted on March 9, 2021. The study was put on hold by FDA on May 10, 2021 with additional comments for the hold provided on June 3, 2021. MAPS provided FDA with a response …
April 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
On April 15, 2022, MAPS wrote the second progress report for our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). The first report was for the reporting period ending January 15, 2022. Read the …
The Effects of MDMA-Assisted Therapy on Alcohol and Substance Use in a Phase 3 Trial for Treatment of Severe PTSD
Highlights A randomized, placebo-controlled, Phase 3 trial demonstrated the safety and efficacy of MDMA-assisted therapy for the treatment of severe posttraumatic stress disorder (PTSD) Participants met …