PIONEER FUND
WHY MDMA-ASSISTED PSYCHOTHERAPY?
Because MDMA-assisted psychotherapy is designed to address one of the main barriers to successful treatment – the stress of reexperiencing trauma in the therapeutic setting – it promises to make therapy dramatically more effective.
In MDMA-assisted psychotherapy, patients suffering from PTSD are given up to three controlled doses, each about a month apart, of methylenedioxymethamphetamine (MDMA)– a psychedelic compound. MDMA is often confused with Ecstasy but it isn’t ecstasy – it’s a medical-grade pharmaceutical agent produced in highly regulated settings and administered under medical supervision.
The use of MDMA in a medical setting dramatically reduces fear and enhances the therapeutic alliance. Used in conjunction with a standardised and manualised form of psychotherapy called Inner-Directed Therapy, the MDMA treatment protocol enables the patient to remember the trauma and work through it without re-experiencing its full, overwhelming and debilitating effects.
Known side effects
In trials to date, safety outcomes were favourable for the use of MDMA in individuals with PTSD in a supportive environment with trained mental health professionals. Based on these very encouraging outcomes on safety and efficacy from trials so far, in 2017 the US Food and Drug Administration (FDA) granted MDMA-assisted therapy a “Breakthrough Therapy” designation.
The treatment showed promise as potentially safe and efficacious for civilians and veterans/first responders with chronic PTSD who had previously failed to respond to pharmacotherapies and/or psychotherapy.
The MDMA-assisted psychotherapy has the weight of science behind it. The MDMA compound has undergone research at Imperial College London, Harvard University, Yale University, Stanford University, New York University (NYU), University of California San Francisco (UCSF), University of Connecticut, University of Wisconsin at Madison, Beer Yaakov Mental Health Center, Israel, the University of British Columbia, Maastricht Hospital, Dept of Neuropsychology and Psychopharmacology, University of Zurich, and elsewhere.
Some of those trials have advanced to Phase 3 – the final stage before medical approval.
In Phase 2 trials in the U.S. and Europe, in patients with severe, treatment-resistant PTSD, 12 months after MDMA-assisted psychotherapy, 67 percent of PTSD patients improved so much that they no longer qualified for the diagnosis. An additional 30 percent had their symptoms notably reduced. That’s in contrast to the 30 percent overall success rate for currently available treatments. At 12-month follow-up, 97.6% of participants across the MDMA trials reported experiencing benefits.
MDMA-assisted psychotherapy promises to be not only more effective than current evidence-based treatments, but potentially also less toxic (because doses are few and time-limited compared to standard drug treatments) and less expensive as well.
Subject to Medicines and Healthcare products Regulatory Agency (MHRA) and the relevant Research Ethics Committees approval, Supporting Wounded Veterans will in early 2021 be looking to refer veterans for screening for a new European Phase 2 trial of MDMA-assisted psychotherapy at King’s College, London. This is in keeping with our purpose – that we, together, can make a change and help veterans overcome the challenges they face.
SUPPORTING WOUNDED VETERANS’ MDMA-ASSISTED PSYCHOTHERAPY PROGRAMME
As part of their support for the programme Supporting Wounded Veterans are able to offer Veterans who volunteer the opportunity to explore the benefits of MDMA-assisted psychotherapy, and by doing so to contribute to research, by participating in a trial at King's College London
We are raising funds for 20 or more veterans to take part in the upcoming Phase 2 and 3 trials at King’s College London. The Phase 3 study planned to start in 2021 will be a substantial part of the application to the European Medicines Agency.The EMA has agreed that it will accept data submitted for FDA approval for MDMA – anticipated in 2022 or early 2023 if results are positive – and require an additional 70 people go through the European trials.
We support this research because we hope it will be a game-changer in this complex and difficult field, and because it is fully consistent with our purpose - that we, together, can make a change and help veterans overcome the challenges they face.
