Psychedelic Research

Most of the 23 treatment-resistant patients in the study were female victims of sexual trauma; two patients were male veterans of the 2003 Iraq war. The patients completed a series of tests to assess the severity of their PTSD, before undergoing a series of therapy sessions – one of which was conducted after taking either MDMA or a placebo. Four days later they underwent further psychological tests and therapy sessions.

After this whole sequence had been completed twice, subjects who received the placebo could then opt to move onto an open-label trial so that everyone could experience treatment having taken MDMA. A total of 21 participants completed all three rounds of the full experimental cycle.

Two months after the last experimental session, psychologist Mark Wagner of the Medical University of South Carolina, who was not involved in any of the experimental sessions, assessed the patients’ PTSD symptoms. Ninety-two per cent of participants had a clinically significant reduction in their clinician-administered PTSD scale (CAPS) scores of 30% or more. Only 25% of the placebo group saw comparable reductions in CAPS scores. No ill-effects were seen in any of the participants.

Mithoefer believes that it is the combination of therapy and MDMA that is effective, and not the drug alone. “Subjects need good follow-up to help integrate the experience because it can stir up strong emotions,” he says.

The independent rater conducted a preliminary analysis of [the Clinician Administered PTSD Scale (CAPS)] scores at baseline and two months later detected a significant condition effect (p. < 0.05). Average baseline scores for people in both conditions were comparable (79.6 for MDMA condition and 78.4 for placebo), but two months after the second experimental session, the average CAPS score for people in the MDMA condition was 27.6, while the average CAPS for people in placebo was 59.1. Eight of 13 participants no longer met criteria for PTSD two months after the second experimental session while only two of eight placebo participants no longer met criteria for PTSD diagnosis. Furthermore, a comparison of baseline assessment of neurocognitive function and assessment two months after the second experimental session did not find any significant differences in either MDMA or placebo participants (Wagner 2008, personal communication). The data examined in this analysis has not yet been subjected to quality assurance and data from one participant remains to be added, but there were few outliers in the data and it is unlikely that additional data will change results.