Therapist Framework

Though many psychedelics have proven to be effective for an array of mental and physical health conditions, none have made it through as much testing as psilocybin. As psilocybin mushrooms continue to break barriers in research studies, therapists are recognizing how important certain aspects of traditional ceremonies and modern practices are in a therapeutic setting, such as having a guide and following a defined framework. By recognizing these important aspects, therapists have started to develop an outline for psilocybin therapy.

It is important to note the difference between integrated therapy and the psychedelic-assisted therapy framework that is being proposed. Integrated therapy is an approach that uses evidence-based practices from multiple therapeutic modalities to enhance conventional care. In terms of psychedelic integrated therapy, counselors do not provide substances or sit with patients who are under the influence during integration sessions. Instead, they offer harm reduction strategies and client-centered care post-trip session. After a patient experiences a psychedelic trip on their own, they will attend a psychotherapy session where they talk about the ways in which the trip affected them and how to use those teachings in everyday life. Psychedelic-assisted therapy, however, requires experienced professionals to administer the substance and sit with their patient before, during, and after their trip. Depending on the substance used, a psychedelic-assisted therapy session can last between two to eight hours.

In the United States, there are very few cities and states that have decriminalized or legalized the use of psilocybin and other entheogens. However, because these laws are only a couple of months to a few years old, many of the developing entheogenic therapy programs are still in their novel stages with pilot programs like TheraPsil’s in Canada paving the way.

Though future programs in the United States may look different, the following is what we know about TheraPsil’s program so far.

TheraPsil is a non-profit patient-rights advocacy group that is currently undergoing a pilot program for psilocybin-assisted therapy. It involves 15 healthcare professionals who are associated with TheraPsil. Each healthcare professional must attend a 10-week training program that is hyper-focused on how to safely facilitate a legal psilocybin-assisted therapy session for cancer patients who experience end-of-life anxiety and other illness-related distress, such as depression and demoralization. Healthcare professionals receive hands-on training by experts on how to facilitate a psilocybin experience. Their training includes didactic coursework and experiential learning that requires each participant to undergo a psilocybin experience in which they are mentored by experts in guiding patients– a process similar to shamans learning from their elders.

The overall learning objective of this program is to properly teach participants how to safely and effectively guide a patient through all aspects of a psilocybin-assisted therapy session. Those who earn accreditation from the program will be included in a pool of qualified healthcare professionals to whom TheraPsil may refer for palliative care for Canadians. Though the program is still in development, TheraPsil has helped 27 Canadians in accessing legal psilocybin-assisted psychotherapy.

If TheraPsil’s pilot program proves to be effective, it can set a great example for the United States and other countries working towards the same goal. With such a wide global push for psilocybin-assisted therapy, there is no reason why a similar framework cannot be implemented in Oregon and the rest of the United States sooner rather than later.

In the states, Oregon is currently working on a similar therapist framework. Though it is still too early to know what that will look like, we can see how certain organizations, such as MAPS, conduct their psychedelic-assisted therapy studies. In 2016, Rick Doblin, founder of MAPS, gave a general outline of how their successful double-blind MDMA studies are conducted.

Doblin states that an independent rater is randomly assigned to one of 230 people and is unaware of the stage their patient’s condition is at (i.e. baseline, one month follow-up, one year follow-up, etc.). During a three and a half month therapy process, the patient must attend weekly psychotherapy. After three weeks, the patient undergoes their first MDMA session. They experience a total of three sessions that are scheduled three to five weeks apart. The session takes place in a special treatment room with a male and female co-therapy team. It takes about 8 hours and the whole process is videotaped. During the session, the patient will communicate with their eyes closed to both therapists. The therapists are not to guide or steer the session in any way, but are merely responding to the material as the patient presents it. This type of setting helps to alleviate the patient’s fears and apprehensions allowing them to better open up and gain new perspectives on traumatic experiences or painful memories.

One company from the UK, Compass Pathways, is currently on track to be the first legal provider of psilocybin. In 2018, Compass’s psilocybin was granted “breakthrough therapy” status by the US Food and Drug Administration (FDA) as a treatment for depression. Once a drug receives breakthrough status, it is pushed through the drug-development process. Compass is currently the only company that has pushed a psilocybin drug this far. The UK company recently filed multiple patent applications that could help them stay at the forefront. Their patents, however, could cause serious problems for other organizations. One example from the past was in the late 80s when the research of for-profit company NDA (New Drug Application International) was brought to a halt due to competing corporate interests in the field which led to intellectual property disputes and debacles. NDA was providing promising ibogaine research concerning opiate addiction in a time where entheogenic plants had the brief opportunity to make culturally significant changes and influence the perspective of pharmaceuticals in society. Alas, corporate and human greed won in this short interim.

After hearing about Compass’ patent, many experts became weary of their intentions. In most countries around the world, including the US and UK, a product can only be patented if it is a new discovery, is not obvious and is not simply “nature”. Since psilocybin is not patentable, much like MDMA, Compass could instead patent a new proprietary manufacturing method. This means other organizations who want to synthesize psilocybin will need to find other ways of doing so. Although this is a tactic typically used in the pharmaceutical world, it is highly unusual in the psychedelic space. Doblin, for example, has gone on record multiple times saying he will not file for patents as he does not want to restrict any research within the field of MDMA. Incredulously, the non-profit organization MAPS has actually been crucial in maintaining anti-patent strategies. Instead of causing restrictions within an industry, Doblin has worked with patent attorneys to conversely open research to everyone, thus leading to more generic and generalized medical practices and an unpatentable approach to clinical psychedelic research.

As Compass’ patent portfolio currently stands, they also have claims that involve basic aspects of psilocybin-assisted therapy, such as set and setting. This includes the appearance, furniture, and decor of the room an administered dose would take place in. Certain behaviors are also claimed in the patent text, such as the patient lying in bed, on a couch, or listening to music. These claims also go beyond the patient and carry over to therapists as well. For example, one claim states “the therapists provide reassuring physical contact.” These practices, however, have been around throughout the history of psychedelics and humanity. For one company to make such claims will only make it extraordinarily difficult for other research organizations to continue their work.

Compass also has a contract with Onyx Scientific— one of the only labs in the world that can produce GMP psilocybin— that prevents them from working with any of Compass’ competitors. Due to this contract, organizations like Usona have been denied by Onyx. In 2017, Usona tried to work with the lab in an effort to study psilocybin as a treatment for depression but was rejected.

In Compass’ effort to stay the leading organization of psychedelic medicine, they have managed to market a sacrament as a pharmaceutical, and have completely appropriated and disrespected the fungi that has helped heal countless of people over thousands of years.

With psychedelic medicine becoming high-profile, many companies are trying to hop on board. The last thing these organizations and therapists want is to make highly effective and therapeutic substances difficult to obtain both for themselves and their patients. Although much of this work depends on laws, regulations, and intellectual property, we can still have hope that the public will gain access to these new forms of therapy with the help of activism and nonprofit organizations.