76% of patients no longer experience PTSD a year after MDMA-assisted psychotherapy
pharmafile | November 6, 2018 | News story | Manufacturing and Production, Research and Development | MDMA, PTSD, mental health, psychotherapy, research
Promising phase II results suggest that MDMA-assisted psychotherapy may be an “innovative, efficacious treatment for posttraumatic stress disorder,” according to a study published in the Journal of Psychopharmacology.
Strikingly, the double-blind, placebo-controlled phase II trial, which supports the case for MDMA as a treatment for PTSD, found that 76% of patients no longer had PTSD 12 months after undertaking their third active-dose MDMA assisted psychotherapy session.
“Consistent with prior research, this study provides supportive evidence that MDMA-assisted psychotherapy can be safe and efficacious in individuals with chronic PTSD refractory to medication and/or psychotherapy,” the Multidisciplinary Association for Psychedelic Studies (MAPS) funded study suggests.
The trial, involving 28 patients with treatment resistant PTSD – the majority of whom had experienced two or more traumatic events, including childhood sexual or physical abuse, combat, ritual abuse, assaults, accidents or witnessing a crime – found that the severity of patient’s PTSD was significantly reduced, 12 months after MDMA assisted psychotherapy sessions. Meanwhile the majority (76%) did not meet the PTSD criteria in an assessment the following year. As such, the findings demonstrate the potential enduring, positive effects of the drug assisted therapy for patients with PTSD.
The paper hypothesizes that MDMA’s ability to bolster prosocial feelings and behaviours, make unpleasant memories more tolerable, and enhance empathy and self-compassion may allow patients the ability to enter an “optimal state of engagement for effectively processing traumatic memories.”
The safety and efficacy of MDMA assisted therapy will now be tested in phase III trials involving 200-300 participants across 16 different sites in Canada, Israel and the United States. It is now hoped that the treatment may receive FDA approval by 2021, if trials demonstrate efficacy and a tolerable safety profile at phase III. MDMA assisted therapy is also currently being trialled for the treatment of social anxiety in autistic adults, and for anxiety related to life-threatening illnesses.
Principal Investigator Marcela Ot’alora commented: “Our study demonstrated that different therapy teams were able to get similarly robust results, further strengthening the case for MDMA-assisted psychotherapy as a promising option for the treatment of PTSD. Plus, the results of the study indicate that this treatment has the potential to greatly improve the lives of people suffering from PTSD, regardless of the source of their trauma. After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges.”
Louis Goss
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