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Psychotherapy and drugs: MDMA can help with post-traumatic stress disorder

Treatment with MDMA, better known as ecstasy, has been shown to reduce symptoms of post-traumatic stress disorder (PTSD) in a small, randomized, double-blind study. The results published in Lancet Psychiatry are now to be reviewed in a phase 3 study, for which the US FDA has already given its blessing. However, approval is not expected until 2021 at the earliest.

The limited success achieved with antidepressants, lithium or benzodiazepines in PTSD has in recent years aroused interest in psychotherapists in attempting therapy with psychoactive drugs such as psilocybin and MDMA. The amphetamine MDMA is intended to support psychotherapy as an “entactogen” or “empathogen” and help those affected to process their traumatic experiences.

For a long time, attempts at therapy were hindered by the strict ban on MDMA. In view of the increasing number of US soldiers with PTSD, some restrictions were lifted and the MAPS initiative (Multidisciplinary Association for Psychedelic Studies) was allowed to treat a total of 26 patients in a phase 2 study between November 2010 and February 2016. Among them were 22 former soldiers, three firefighters and one police officer. None of them responded to conventional therapy.

The study took place at a treatment center in South Carolina. Since some participants had already had experience with ecstasy in the past and the effects of the drug are well known, a placebo-controlled study design was not possible. The participants were therefore treated with three different doses, with 30 mg being classified as an active control, while an effect was expected above all at the doses of 75 mg and 125 mg.

All participants had taken part in three therapy sessions prior to the study in order to build a therapeutic alliance. They then took the drug at the beginning of a fourth session. For a total of eight hours, they were accompanied by a duo of a male and a female therapist, who spoke to the patient about the traumatic experience in a non-directive manner. The aim was to move this to an area of ​​memory that is not related to the physical reactions that lead to horror and sleep disorders in patients with PTSD. The patients spent the night after the therapy sessions in the treatment center. Thereafter, the therapists initially kept in daily contact with those affected for over a week and in three subsequent therapy sessions the experiences during the MDMA sessions were discussed. Each treatment consisted of 18 hours of non-MDMA-assisted plus 16 to 24 hours of MDMA-assisted psychotherapy.

The effect of the therapy was assessed one month after the second session using the fourth version of the Clinician-Administered PTSD Scale (CAPS-IV). As a team led by Allison Feduccia from the MAPS Public Benefit Corporation in Santa Cruz / California has now announced, the 75 mg MDMA dose reduced the CAPS IV score from 82.4 to 24.1 points. Six out of seven patients (86 percent) in this group no longer met the criteria for PTSD (over 50 points in the CAPS-IV). At the higher dose of 125 mg MDMA, there was a decrease from 89.7 to 45.3 points. In this group, seven out of twelve patients (58 percent) were no longer suffering from PTSD. In the control group there was an improvement from 87.4 to 76.0 points. Two out of seven patients (29 percent) had overcome their PTSD.

Feduccia attributes the better effect under the lower of the two therapeutic doses to the better ability of the patient to concentrate on the conversation with the therapist. In view of the small number of participants, however, a coincidence cannot be ruled out. In the meantime, the participants in the control group have also received two MDMA-supported therapy sessions. In all patients, the success of the therapy was still demonstrable in a final examination after twelve months. Admittedly, side effects such as anxiety, headache, fatigue, muscle tension and insomnia occurred at all dosages. However, there were no serious complications.

The FDA has since approved a phase 3 study to begin in summer 2018. The study will be conducted at centers in the United States, Canada, and Israel. The FDA has been supporting the clinical development of MDMA since August last year by classifying it as a "Breakthrough Therapy Designation". If the study is successfully completed, the cost of which is estimated at around US $ 27 million and is generated from donations, the MAPS initiative will be granted exclusive marketing rights for the substance that Merck developed during the First World War. The MAPS initiative contacted the European Medicines Agency to discuss the conditions for approval. rme

Feduccia A, Mithoefer A, Wagner M: 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomized, double-blind, dose-response, phase 2 clinical trial. Lancet Psychiatry, May 1, 2018, DOI: S2215–0366 (18) 30135–4.