UK Brain Imaging Study to Explore MDMA’s Effects on PTSD without Therapy

The Cardiff University MDMA for PTSD Project
In Association with MAPS and The Beckley Foundation

Since meeting Rick Doblin and Michael Mithoefer in Basel in 2006 it has always been my intention to bring an MDMA for PTSD study to the UK. After meeting Jon Bisson, an ex-Marine and now the PTSD lead at the UK’s Royal College of Psychiatrists, in 2010 our original intention was to repeat Michael’s 2010 published study, delivering MDMA Psychotherapy to patients with treatment-resistant PTSD. 

But in 2012, after an initial funding rejection from the Medical Research Council for a proposed large-scale therapeutic project, we decided to scale things down. Hooking up with the neuroimaging expertise of Robin Carhart-Harris, Ph.D., and Prof. David Nutt at Imperial College London and Richard Wises’ fMRI department at Cardiff University we designed a study that looks primarily at the neurobiological mechanisms behind MDMA’s effects on the core features of PTSD. There have already been neuroimaging studies on patients with PTSD and on healthy people taking MDMA, but ours will be the first time fMRI has looked specifically at patients with PTSD under the direct effect of MDMA. This study will be funded by MAPS, Beckley Foundation and an anonymous donor. There is no therapeutic component to the study, but subjects will be able to request therapeutic support if they feel it is necessary since for most of their MDMA experience they will not be in the scanner. This study will also explore MDMA’s potential beneficial effects without delivering formal therapy.

We know from the results of underground MDMA therapy, from anecdotal studies of the 1980s, and from Michael and Peter’s recent work that MDMA Psychotherapy works, but there remains a lack of data about the mechanism behind its effects in PTSD. There are neuroimaging studies on patients with PTSD and on healthy people taking MDMA, but ours will be the first time fMRI has looked specifically at patients with PTSD being given MDMA. We hope this initial, mechanism of action phase of the Cardiff University MDMA for PTSD Project will generate supporting future studies designed to demonstrate MDMA’s overall efficacy and safety. It provides important data to support Phase 2 of the drug’s clinical trials and is therefore a crucial part of the broader project to explore how MDMA works in the brain ahead of Phase 3 studies, which are aimed at seeing MDMA licensed as a medicine to be used by clinicians to treat PTSD. 

We are now at the stage of submitting for ethical approval (like the US IRB process) and seeking a Schedule 1 license for MDMA to be used at Cardiff. Rather excitingly, Mat Hoskins, the other study doctor on the project, and myself are soon to undergo MDMA Therapy training with Michael and Annie Mithoefer. This initial phase the Cardiff project should begin in early 2015 and take around two years to complete. Thereafter we hope to design further studies to explore different models for delivering MDMA Therapy for PTSD. It may be that a form of MDMA Therapy can be used in brief, focused, more clinically deliverable formats than some of the current proposed models.

The financial, academic, and inspirational support from MAPS has been invaluable; the lubrication that got the cogs of our machine turning. The Beckley Foundation has also been involved in the development of our project. We look forward to many years of continued close work with these and other members of the international psychedelic research community.

—Dr Ben Sessa MBBS (MD) BSc MRCPsych
Consultant Child and Adolescent Psychiatrist in Substance Misuse and Psychedelic Researcher, Bristol and Cardiff, UK