MDMA-assisted therapy research

Veteran Enquiry Information 

for the Phase II Feasibility Study of Manualised MDMA-assisted psychotherapy

in veterans with Post Traumatic Stress Disorder

Supporting Wounded Veterans (SWV) has been working 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 MDMA-assisted therapy in the treatment of Post-Traumatic Stress Disorder (PTSD) clinical trial to the UK.

 

The clinical trial will be conducted and delivered by expert clinicians and researchers at the IoPPN, King’s College London.  

This new clinical trial builds on many years of research in the US, led by MAPS. 

 

This webpage outlines how to enquire about being a participant in the trial, including information regarding the enrolment process provided by MAPS & King’s College London below. Please read all of this information before submitting your contact details. 

The roles and responsibilities of SWV in the MDMA-assisted therapy for PTSD trials is to a) provide fundraising and advocacy and b) confirm veterans' proof of service for King's College London. This is explained in more detail below. 

Enquiry process for veterans

  1. Read through this introductory information

  2. Complete the contact details form and submit your proof of service documents

  3. SWV will check and verify your veteran status

  4. If verified as a veteran, SWV will send your name and email address to the clinical trials team at King's College London

  5. The King's College London team will contact you to inform you of the enrolment and screening process 

Fundraising and advocacy

SWV is a charity which supports UK veterans who have been medically discharged or have been wounded, are ill or injured, physically and/or psychologically.

 

It has been leading a £1.5m fundraising appeal to fund a UK clinical trial to research a new treatment for chronic and severe PTSD in veterans. Through its programmes for veterans with physical and psychological injuries, it understands that PTSD is a huge barrier for veterans wishing to transition successfully to civilian life. 

 

SWV is supporting this new clinical trial to explore whether this treatment option is more effective than existing treatment options.

 

You can read more about SWV’s fundraising appeal here.

Veterans' proof of service

 

SWV is supporting King’s College London by sharing the details of this project within the veteran community to ensure all those who apply are former servicemen and women. 

 

Please only enquire and share your contact details with us if you can provide your proof of service as a former member of the British armed forces and are a veteran. 

 

Veterans are defined as anyone who has served for at least one day in Her Majesty's Armed Forces (Regular or Reserve) or Merchant Mariners who have seen duty on legally defined military operations.

 

Please note, SWV is not part of the enrolment or screening process and will not have any involvement in the trial participant selection, or in any part of the trials. This will be managed directly and solely by the clinical team at King’s College London and the Sponsor of the trials, MAPS. 

 

You can express an interest in this research trial by submitting your details and providing the consents set out in the form below. Once SWV has successfully verified your veteran status, then when the trials open for participant enrolment, SWV will send your name and email address directly to the clinical team at King’s College London.

Helping you to manage expectations of the clinical trial process  

 

Data generated by a series of international clinical trials suggests that MDMA-assisted therapy may have significant therapeutic utility in the treatment of PTSD that is unresponsive to conventional treatments. However, it is important to note that this is an experimental treatment that is still very much under clinical investigation and that the effectiveness of the treatment has yet to be established. 

 

Furthermore, as it is a trial that must comply with strict regulatory safety guidelines dictated by the Medicines and Healthcare products Regulatory Agency (MHRA), a narrow inclusion criterion will be applied. As such, it is likely that a significant proportion of applicants may be excluded from participating in the study. This will be determined by the clinical team at King’s College London via a series of medical and psychiatric assessments. 

 

In addition, it is important to note that outcomes may vary for those enrolled on the study, and so we encourage applicants to consider the treatment not to be a final and ultimate solution for their PTSD, but rather a treatment that may help facilitate a meaningful psychological process. Participants will also benefit from, and possibly require, further engagement with the study, even after the conclusion of the trial.

 

SWV veterans' pathways

 

SWV supports former servicemen and women who have physical or psychological injuries with opportunities and activities to regain their independence. It does not provide clinical treatment options for the treatment of PTSD as there are many organisations within the healthcare and voluntary sector who are equipped to do this.

 

To support the clinical trials, SWV is working with Op Courage, the Veterans Trauma Network and other military charities to signpost to further support for those who do not meet the eligibility criteria for the trials; those who have not benefitted from participating in the trial; and/or those who benefitted from their participation but are in need of additional mental health support.

 

SWV's vision for the future

 

SWV is committed to securing the funds and a wide range of support from across the military and healthcare sectors for the research to take place and for the development of novel, safe and effective treatments for veterans suffering from complex physical and/or mental ill health.

 

SWV is hopeful that the treatment will prove to be safe and effective in clinical trials in the UK, and if so, that it will eventually be approved and licensed as a treatment for chronic and severe PTSD. Should the treatment be licensed for wider clinical use, we hope that some of the excluding factors will be modified to allow for a wider patient group to access the treatment. Therefore, applicants excluded from the clinical trial at King’s College London, may be able to access the treatment if and when it is approved. 

If you have any questions about how to express your interest in this clinical trial please contact:

Catherine Bird, Clinical Trials Manager, KCL

catherine.bird@kcl.ac.uk