By Tessa Eskin
The past decade has seen numerous clinical trials focused on the medicinal and psychological benefits of psychedelics. The results couldn’t be more promising, and yet the next steps of psychedelics are the most crucial. Psychedelics are still registered as Schedule 1 substances, despite evidence that they are neither addictive nor widely abused. This restriction means that psychedelic-assisted treatments are withheld from patients. Red tape, paranoia, and outdated stigma have kept medicine from those who need it most.
Change is in the air, though. The Multidisciplinary Association for Psychedelic Studies (MAPS) is soon to complete Phase 3 trails on MDMA-assisted psychotherapy for PTSD. It follows the success of their Phase 2 trials, which showed groundbreaking results.
MAPS recruited 105 participants with severe PTSD. The majority of subjects had attempted various treatments in the past, without lasting success. After receiving just three sessions of MDMA-assisted psychotherapy, the subjects reported incredible improvements to their mental health. 12 months on, 68% no longer suffered any symptoms of PTSD. Follow-up studies over three years later confirmed that the results were long-lasting. The evidence is clear. MDMA-assisted psychotherapy represents the next steps of psychedelic treatment, and is more effective than any other for PTSD.
With Phase 3 in the final stretch, the results will likely be just as statistically significant. Once the numbers are confirmed, the FDA will approve MDMA-assisted psychotherapy for PTSD treatment.
PTSD, MDMA, & Psychotherapy – How Does it Work?
For context, PTSD is notoriously difficult to treat. The disorder affects roughly 8 million adults any given year. Many patients who are resistant to traditional treatment have little recourse. In fact, it’s been 17 years since the release of the last new medication for this disorder. PTSD damages relationships, careers, and wellbeing. It often causes increased depression, which in some tragic cases, leads to suicide. So, how exactly does MDMA-assisted therapy help push patients through the hurdle of recovery?
Psychotherapy is a partnership between therapist and patient, one that depends on trust, candidness, vulnerability, and an open mind. The problem is that PTSD often causes distrust and defensive tendencies. Deeply ingrained fear responses can keep the walls up, making it difficult to process the root of traumatic experiences. Psychological healing can be very challenging under these circumstances.
MDMA combats this by releasing serotonin, norepinephrine, and dopamine into the system, as well as increasing neurohormones oxytocin levels. It accelerates emotional processing and lowers activity in the amygdala, the part of the brain responsible for processing fear. This cocktail of reward system chemicals reduces defensive responses while enhancing compassion, social connection, and introspection. Patients are more likely to trust therapists and engage with deep internal processing around their fears and trauma.
The Therapeutic Process
The psychotherapy sessions last for about 6-8 hours. Patients ingest the MDMA and begin with guided relaxing breathwork. They spend much of the session reclined, listening to music and going within. Two specially trained therapists guide the session – generally a male and a female, a recommended arrangement for those with childhood trauma. The next steps include therapeutic and supportive conversation.
MDMA is a known catalyst for profound breakthroughs and insights into the self. In a therapeutic setting, it raises awareness of different aspects of the psyche. This allows patients to safely explore difficult mental and emotional states with clarity and compassion. Therapists involved in these trials report that many patients come to unprompted breakthroughs and epiphanies on their own. The participants themselves have likened MDMA to an “inner healer”, or a spring cleaning of the mind. It gives patients the courage and space to deal with traumatic memories and process deep-seated fears.
MAPS is currently working through the final rigorous stages of the Phase 3 trials. Their priority now is to confirm the safety and efficacy of the treatment, the last step toward obtaining FDA approval.
The final studies are double-blind, placebo-controlled randomized trials taking place across the US, Canada, and Israel. The coronavirus pandemic delayed the trials, but 90 of the 100 subjects have already completed the process. Still, the FDA is working with MAPS to ensure approval as soon as possible. A recent third-party analysis of the data collected so far revealed a 90% probability that the results will be successful. Put simply, MAPS is well on its way to meeting the FDA’s requirements.
These trials represent the future of psychedelics and are bound to open the gates to further legalization, normalization, and patient access. MAPS aims to commercialize the treatment by 2023, a milestone few had dreamed of prior to these trials. It’s even estimated that there will be up to 6000 psychedelic clinics open by 2030, ushering in a new era for mental health treatment.