THE SCIENCE BEHIND MDMA-ASSISTED PSYCHOTHERAPY
MDMA – full name, methylenedioxymethamphetamine – is a psychedelic drug. In fact, an ingredient in the street drug Ecstasy. But the drug used in MDMA-assisted psychotherapy is not Ecstasy (which often includes other psychoactive agents). Before it was hijacked by the party scene, it was a medicine used in therapy – and now it will be used that way again. It is a prescription-grade drug. The FDA (US Food and Drug Administration) and EMA (European Medicines Agency) have authorized MDMA for use in clinical investigations, and the FDA has approved it for compassionate use in an expanded access Programme for patients.
In trials so far, MDMA has been shown to make traditional talk therapy for PTSD dramatically more effective.
Among the greatest challenges in PTSD treatment is that therapy requires the patient to re-experience the trauma. But in established treatments – such as traditional psychotherapy and neurological methodologies including Eye Movement Desensitisation and Reprocessing (EMDR) – the fresh experience of the original trauma can cause fear and stress that undermine the effectiveness of the therapy.
Initial research shows that limited, controlled treatment with MDMA counteracts that fear response. The result is that patients can more easily engage with and process their trauma during traditional psychotherapy.
Additional studies show that MDMA-assisted psychotherapy is equally effective for PTSD from many causes, such as child abuse, sexual violence, and torture.
MDMA-assisted psychotherapy also promises to be more cost-effective than other treatments. The treatment and research cost will be £30,000 per veteran for the trials at Kings College London. This contrasts with £50,000 for six months of inpatient treatment at the Bethlem Royal Psychiatric Hospital in London. These figures represent direct costs, but the effectiveness of MDMA-assisted psychotherapy has the potential to reduce the social cost of family breakdown, unemployment, and other impacts. Once MDMA-assisted psychotherapy for PTSD has been approved for use by prescription, the treatment cost will be a fraction of the trials cost.
MDMA-assisted psychotherapy is currently in Phase 3 trials – the final stage before regulatory approval – at 14 sites across the world in the USA, Canada & Israel. Additionally Phase 3 research sites are being established in the UK, The Netherlands, Czechia, Portugal, Germany, and Norway to develop data to submit for approval from the European Medicines Agency (EMA). Research is in the early planning stages in South Africa, Somaliland and Australia. These trials are for people with PTSD from any cause, mostly veterans, first responders, and rape, sexual abuse, and domestic violence victims.
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.