A Phase 3 clinical trial in the US shows therapy on ecstasy could treat severe PTSD.

MDMA-assisted therapy is safe and effective for the treatment of people with severe post-traumatic stress disorder (PTSD), according to results of a recent trial published in Nature Medicine. 

This study was granted an ‘Breakthrough Therapy’ designation from the US Food and Drug Administration (FDA), and provides a new treatment option for people who suffer from PTSD.

Selective serotonin-reuptake inhibitors are the FDA-approved first-line therapeutics for the treatment of PTSD, but nearly half of patients do not respond to these drugs. 

The amphetamine MDMA (also known as ‘ecstasy’) also targets the serotonin system and has shown promise in animal and early clinical studies as a treatment for PTSD.

University of California researchers conducted a phase 3 randomised clinical trial during which MDMA was administered to 90 participants, in conjunction with manualized therapy, over the course of 18 weeks. 

The authors found that MDMA was well tolerated in patients with severe PTSD, and observed a significant and robust reduction in symptoms relative to those of patients receiving a placebo combined with a similar therapy. 

This treatment approach was also effective in patients with associated comorbidities, such as childhood trauma, dissociation and depression.

These results suggest that, compared with current first-line pharmacological and behavioral therapies, MDMA-assisted therapy has the potential to be a beneficial new treatment for patients with PTSD.

It is the latest in a series of studies sponsored by the non-profit organisation MAPS (the Multidisciplinary Association for Psychedelic Studies). 

MAPS hopes that the MDMA-assisted therapy approach will be approved in 2023 by the FDA.