Skip to main content
Health

An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA- Assisted Psychotherapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder

Vetera

Aims

The effects of PTSD can be extremely debilitating and current treatments aren’t always effective.

With support from the Multidisciplinary Association of Psychedelic Studies (MAPS) we are trialling MDMA therapy for PTSD for veterans. This study will include brain-scanning and blood-based measures to investigate differences in treatment response.

Methods

This is a phase 2, open-label trial investigating MDMA therapy as a treatment for posttraumatic stress disorder. This trial is only open to veterans.

Participating in the trial

If you wish to volunteer for this trial, please consider your decision carefully. There are strict inclusion and exclusion criteria the team cannot deviate from. You will be usually asked to attend the research facility on numerous occasions, without much flexibility for variation in dates. Clinical trials are not the same as receiving treatment from your doctor or therapist. We use placebos or variable doses in some of our trials. You may not get the treatment you want and the team is unable to change this, for any reason.

For one reason or another, most people who volunteer turn out not to be eligible for a clinical trial. It’s important to be realistic about the chances of inclusion and pursue other sources of help at the same time.

Effects of Psychedelics

Depending on the drug, psychedelic therapy lasts from about 2 to 8 hours. We only give people psychedelics in a dedicated hospital facility with support from doctors, nurses, psychotherapists and study coordinators. We don’t give people psychedelics to take home.

It isn’t possible to predict how psychedelics will affect an individual person. Clinical trials are an experiment. They are being done because we do not yet know if psychedelic therapy is a safe and effective form of treatment. Therefore, your participation in a trial comes with some risks. Your condition could improve, stay the same or it could worsen.Psychedelic therapy is not a ‘reset’ for your brain and it is not a ’quick fix’. Regardless of what happens, it’s important to have the right support around you if this happens. There are limits to the extent the study team can support you, particularly out of normal office hours.

Trials Design

Status

Open for recruitment

Participants

Adults, Veterans only

Clinical area

Post traumatic stress disorder

Intervention

MDMA therapy

Recruitment period

2022-2023

Contact

MDMA@kcl.ac.uk

Funder

Supporting Wounded Veterans

Sponsor

Multidisciplinary Association for Psychedelic Studies (MAPS)