This unregistered trial (n=6) was a double-blind, placebo-controlled pilot of low-dose MDMA-assisted psychotherapy for chronic PTSD in women, which was terminated early following regulatory intervention by the Spanish Health Ministry.
This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.
The study investigated the safety and preliminary efficacy of low-dose MDMA (50–75 mg) administered within a psychotherapeutic setting. The participants were women with chronic post-traumatic stress disorder (PTSD) resulting from sexual assault who had previously failed to respond to standard treatments.
Although the trial was originally designed to include 29 subjects, it was terminated early due to regulatory intervention by the Spanish Health Ministry. Preliminary results from the six participants treated indicated that the low doses of MDMA were both psychologically and physiologically safe.
Single dose of 50 mg MDMA administered in a psychotherapeutic setting.
Administered in a psychotherapeutic setting with 6 psychotherapy sessions (3 before, 3 after).
Single dose of 75 mg MDMA administered in a psychotherapeutic setting.
Administered in a psychotherapeutic setting with 6 psychotherapy sessions (3 before, 3 after).
Placebo dose administered in a psychotherapeutic setting.
Administered in a psychotherapeutic setting with 6 psychotherapy sessions (3 before, 3 after).