King's College London

Aims

In this research study, LSD is being tested for the treatment of generalised anxiety disorder (GAD).

The main purpose of this study is to investigate how well one initial administration of MM120 (LSD) works to lessen the severity of symptoms in GAD within the first 12 weeks of treatment and to determine the durability and long-term safety of MM120 over approximately one year (56 to 58 weeks).

Methods

A Phase III, multicentre, randomised, double-blind,controlled study to investigate the efficacy, safety, and tolerability of MM120 in participants with GAD.

Participants enrolled in this trial will be randomised to receive either 0µg, 50µg or 100µg of LSD. There will also be potential option to participate in an Open Label Extension, where all participants could receive up to 4 doses of 100µg of LSD.

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, with only some 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.

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

LSD lasts for around 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.