The recent publication in Nature Medicine on the Phase 3 study of MDMA-assisted psychotherapy has created another wave of exuberance around psychedelic medicine. Mainstream media is now flush with articles and news segments about the findings, so I will not go into detail about those. Just for context, the general findings were 67% of PTSD sufferers who had MDMA with psychotherapy no longer qualified for a PTSD diagnosis following the trial, compared with 32% of those who received a placebo with psychotherapy. And 88% of subjects in the MDMA group experienced a “clinically significant improvement” in symptoms.
I often hear questions regarding safety and abuse potential regarding the likely FDA approval of this therapy. Therefore, I think this is a good opportunity for those who are unaware of this trial and their protocols to learn how participants are actually treated. More importantly, what does this mean for potential real world use. There is a misconception that MDMA will be prescribed to people which will eventually lead to the next epidemic on top of an existing opioid epidemic. The study participants only received three medicine treatments. Three. Administered in a facility under the supervision of medical personnel. There seems to be a reflexive answer to the use of psychedelics as medicine among parts of the psychiatric and addiction community. Drugs = Bad, no matter what context. It is just not that simple, certainly not after legitimate research is demonstrating continued efficacy and minor adverse effects.
When this therapy becomes FDA approved it will be administered under the same conditions – in a controlled setting. Patients will not be receiving prescriptions, therefore overdoses and diversion will be impossible. IIT has created a protocol that mirrors much of what is happening in this trial. What we have learned using Ketamine is the same the science has demonstrated with MDMA – the drug is only part of the equation. Current literature has shown that the greater the mystical experience, the better the outcomes. This was found regardless of dose received. Secondly, the drug without the therapy had waning effects and more adverse effects. Essentially, giving the drug alone without a therapeutic framework was problematic and did not produce lasting improvement.
There is much work to be done before IIT will offer MDMA-assisted psychotherapy, but when that day comes, we will be providing an ethical and safe practice. One that we believe will build upon the hard work done on these trials to create a protocol that maximizes the therapeutic benefit of this powerfully important medicine.
Recently, an article was published in the NEJM comparing psilocybin (the key ingredient in "magic mushrooms") to escitalopram. Current literature comparing psilocybin to established, first-line treatment has been lacking, so this was a much anticipated study. The small study was comprised of two groups – one received two separate doses of 25 mg of psilocybin three weeks apart, plus six weeks of daily placebo pills; the other received two separate doses of 1 mg of psilocybin three weeks apart, plus six weeks of daily oral escitalopram, an SSRI. The SSRI group’s low psilocybin dose was considered so low that they were unlikely to have an effect, in other words a placebo dose.
The study was small (30 in the psilocybin group and 29 in the SSRI group) but still provided key findings that require context when evaluating. Both groups showed a reduction in Quick Inventory of Depressive Symptomatology scores (QIDS-SR-16), which is a self-reported survey that is used to rate depressive symptom severity. Reduction in depression scores of at least 50%, was seen in 70% of people in the psilocybin group, compared with 48% in the SSRI group. These results are great in that psilocybin group had more symptom reduction but unfortunately the statistics proved that the difference was insignificant.
But that’s okay…
Even if the effect proves to be the same after larger trials have completed, we must look at the bigger picture. The patients who had psilocybin therapy only had two sessions, while the SSRI group took a medication every single day. In other studies, psilocybin has been shown to have lasting effects that do not require frequent psychedelic therapy. We have to consider that when people start on SSRIs they are often are committed to them for life. A therapy provided intermittently versus a daily medication is not an insignificant difference. Another important distinction is that SSRIs have adverse effects too. In fact, the SSRI group in this study reported more adverse effects, including anxiety and decreased libido. Psilocybin’s main adverse effect was a headache the next day. Those are not minor differences.
The primary outcome of interest was a self-reported score, QIDS-SR-16. The statistically insignificant difference got a lot of the attention as a win for conventional treatment. However, secondary outcomes for psilocybin included enhanced feelings of connectedness with the self, others,and the world; enhanced ability to confront, process, and accept difficult emotions that had been suppressed; and catharsis and release of long-term grief and other avoided emotions.
This is why the Science can be deceiving. The primary outcome is not reflective of psychedelic therapy’s real potential. Curing depression is the wrong endpoint. Helping people connect with others again and grow from past trauma is the ultimate endpoint.
DISCLAIMER: IIT does not endorse recreational use of psilocybin.In this study, all participants received psychedelic-assisted psychotherapy under the supervision of a trained guide and oversight by a physician. IIT provides psychedelic therapy in Minnesota with the same protocols but with Ketamine only at this time.
We will be using this platform as a means of communicating to you news in the field of psychedelic medicine, as well as updating you on the services that we provide at the Institute for Integrative Therapies.
The Institute for Integrative Therapies will be opening a new psychedelic-assisted therapy clinic in St. Paul, Minnesota on May 1st, 2021. We are excited to be opening our second clinic and providing this cutting-edge treatment to more people in need of support. IIT’s aim is to help make the Midwest a hub for furthering this re-emergent field, through the delivery of psychedelic-therapies, research, public education and interdisciplinary community-building.
The growing rates of depression, anxiety, and other mental health illnesses have contributed to a national mental health crisis in the United States and call for new and unconventional treatment options. Recent research around therapeutic psychedelics suggests that these powerful substances may hold tremendous power in addressing such an urgent public health epidemic.
Psychedelic-Assisted Therapy is actually not a new treatment, however due to the cultural revolution of the late 1960s, along with the failed war on drugs, this field froze over for several decades. Over the last 20 years, this field has slowly started warming, and is on the brink of reaching critical mass, on the precipice of breaking back into the mainstream. Currently, Ketamine is the only legal substance used for these therapies in most states, including the state of Minnesota.
IIT is a company that delivers psychedelic medicine safely and ethically with the goal of helping Minnesotans find new ways to approach their lives. Currently, the Institute for Integrative Therapies offers Ketamine-Assisted Therapy for a variety of mental health conditions, including anxiety, depression, PTSD, OCD, end of life anxiety, religious trauma and grief & loss. This therapy is often times useful for people who are stuck and may not be responding to traditional talk therapy or psychiatric medications.
In the near future, the Institute for Integrative Therapies will be offering MDMA and eventually psilocybin-assisted therapy, as these substances are rescheduled by the DEA and become available for clinic use. MDMA-assisted psychotherapy is a breakthrough therapy that has completed its last phase of a clinical trial for PTSD and could be approved by the FDA by the end of this year. About a third of patients with depression and anxiety do not respond to the traditional, medical model. Of those, 50-80% have been shown to respond to Ketamine. As the National Institute of Mental Health reports, Ketamine “might be the most important breakthrough in antidepressant treatment in decades.” IIT’s mission is to create a new model of care that employs a more holistic approach to care by leveraging the power of this transformative experience.
Additionally, IIT emphasizes the power and role of “set and setting” in optimizing the psychedelic therapy experience. IIT does this through the integration of art, music and design in the therapeutic process. IIT curates personal experiences for each client and uses creativity and collaboration to determine the best course of treatment.
Dr. Manoj Doss is the board-certified, medical director for IIT, and a leader in the emerging field of Psychedelic Assisted Psychotherapy. Kyle Keller holds a certification in Psychedelic Assisted Psychotherapy from the California Institute for Integral Studies and is a practicing psychedelic-assisted therapist. He is also the co-founder of Ellie Family Services. Erin Pash is the CEO and founder of Ellie Family Services, and a local leader in mental health education and advocacy. Kyle Ross is the director of community-based services at Ellie Family Services, specializes in complex trauma and is a Ketamine-assisted psychotherapist. IIT provides services in partnership with Ellie, one of the fastest growing psychotherapy agencies in the Twin Cities, with more than 150 therapists.