MDMA-assisted therapy research for treatment-resistant PTSD in Veterans: End of trial report – August 2024

Abstract: Supporting Wounded Veterans (SWV) has worked in conjunction with the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, the Multidisciplinary Association for Psychedelic Studies (MAPS) and NHS England to bring the first Methylenedioxymethamphetamine (MDMA)-assisted therapy in the treatment of moderate to severe treatment-resistant Post-Traumatic Stress Disorder (PTSD) clinical trial to the UK. This research was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and approved by the Health Research Authority (HRA). The MDMA-assisted therapy research consisted of two trials executed in the USA and five sites in Europe, including this trial in UK: 1) Phase II Trial (MP18): an Open-Label, Phase II, Multicentre Feasibility Study of Manualised MDMA-Assisted Psychotherapy in subjects with PTSD. 2) Phase III Trial (MAPP3): A Multicentre, randomised, double-blind, inactive placebo-controlled study of the efficacy and safety of MDMA-assisted therapy in veterans with severe PTSD. The research was subsequently reduced to Phase II only, the Safety part of the Trial. MAPS made the unexpected decision to focus on the US market only and further research in UK and Europe was halted. On 9 January 2024, the MAPS Public Benefit Corporation rebranded to Lykos Therapeutics but will be referred to as MAPS throughout given the study completed in December 2023 while still branded as MAPS. For Phase II (Safety) the MHRA recommended having five veterans only due to MAPS having completed their own Phase II Trials successfully. Five UK veterans with experience of moderate to severe PTSD were recruited to take part in the trial, with each participant receiving a combination of MDMA and established talking therapies. The initial trial was successful. The treatment was well tolerated by the veterans, refined operational processes and provided the trials team with the confidence to proceed to the next stage including the potential for larger trials. The latter ability would enable more veterans suffering with PTSD to be potentially treated in a shorter timeframe.

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