Melissa Warner – Education and Communications Officer
Paul Liknaitzky – Advisory panel member
In the treatment of PTSD, both pharmacotherapy and psychotherapy present additional challenges. PTSD is notoriously hard to treat, with current anti-depressant pharmacotherapy achieving relief from symptoms in about 20%-30% of sufferers[i]. In psychotherapy, PTSD patients have a high drop our rate of 30%. Therapeutic efficacy may be limited by a patient’s ‘narrow therapeutic tolerance’, caused by the anxious arousal associated with traumatic memory[ii]. Current treatments are ineffective for up to 50% of PTSD patients enrolled in clinical trials[iii].
The last 15 years has seen a resurgence in psychedelic-assisted treatments for mental illness. Evidence is mounting for the safety and efficacy of MDMA-assisted psychotherapy for Post-Traumatic Stress Disorder. Final phase 3 trials have commenced. There are a number of well-controlled Phase 2 trials that have shown excellent safety and remarkable treatment effect sizes. Indeed, many mental health experts are now paying close attention to this resurging field, in the hope that MDMA-assisted psychotherpay may offer breakthroughs in mental health treatment of the likes we have not seen in decades.
Through a series of worldwide trials, The Multidisciplinary Association for Psychedelic Studies (MAPS) has finalised Phase 2 trials for the use of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD). Participants underwent two or three 90-minute preparatory psychotherapy sessions which was followed by two to three supervised MDMA (or placebo) sessions. The data across these trials was collated for a paper in Psychopharmacology which showed MDMA has a 50 percent efficacy rate for treatment-resistant PTSD sufferers, compared to 23 percent in the placebo group. The six trials included in this study were conducted between 2004–2017 with a total of 103 participants. It was also found that once treated with MDMA, patients continue to improve as observed in subsequent follow ups a year later with 68% in remission at this time point[iv].
In fact, MDMA has been granted ‘Breakthrough Therapy’ status by the US Food and Drug Administration (FDA), expediting the transition to prescription medicines subject to positive outcomes within current trials[v]. This designation highlights the FDA’s anticipation that these MDMA-assisted therapy may offer substantial advantage over current treatments. Critical data is expected to be released within the next. If these results confirm the treatments to be effective, MDMA for the treatment of PTSD may become available as early as 2021 in the US and psilocybin for the treatment of depression within the next five years in some countries. MDMA has recently been approved for advanced access (Compassionate Use) in Israel for patients who have not improved with current modalities. Likewise, MDMA is pending approval for a similar program (Expanded Access) in the USA.
[i] Stein, D. J., Ipser, J., & McAnda, N. (2009). Pharmacotherapy of posttraumatic stress disorder: A review of meta-analyses and treatment guidelines. CNS Spectrums, 14, 25–31
[ii] Thal S, Lommen M. (2018). Current Perspective on MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder . Journal of Contemporary Psychotherapy 48, 99–108
[iii] Mithoefer, M., Wagner, M., Mithoefer, A., Jerome, L., & Doblin, R. (2011). The safety and efficacy of ± 3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: The first randomized controlled pilot study. Journal of Psychopharmacology, 25(4), 439–452.
[iv] Sessa, B., Higbed, L., & Nutt, D. (2019). A Review of 3, 4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy. Frontiers in Psychiatry, 10, 138.
[v] Maps.org 2017. FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials