New Psilocybin study published in NEJM
The New England Journal of Medicine is a prestigious public access medical journal. Public access journals offer full text research without ever charging readers. Under the Psychiatry tab, a number of psilocybin related clinical trials, editorials, and literature reviews can be found.
This new editorial presents numerous points regarding patient safety and the forecast of the psychedelic wave. The author also provides a brief, yet clear analysis of a recent Phase 2 clinical trial. I recommend you check it out. Below, I will respond to this piece and provide sources.
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To view, copy this link and paste to your search bar! https://www.nejm.org/doi/full/10.1056/NEJMe2210975
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This is the study Dr. Madras reviewed
Psychedelic Therapy: Hot New Technique? Or Illumination of Existing Practice?
The safety of psilocybin mushrooms has been investigated before. We must consider the global studies (1) that have ranked psilocybin as the safest recreational compound in the market. In 2010, a study found (2) that there were 32 million lifetime users of psychedelics in the United States. In only one survey, 17% of respondents aged 21-64 reported multiple psychedelic experiences with the use of psilocybin or LSD (a potent psychedelic compound that comes from a fungus growing on ergot). This result deserves attention because it has an overwhelmingly large positive trend even though surveys can sometimes be incomplete. Patients often withhold information in medical questionnaires. Gurmankin Levy, et al found that the most common reason for patients to withhold medical or drug use information from their physician was the fear of being judged or lectured (5). During this survey, participants could have lied in fear of prosecution (3). Magic mushrooms lead to the lowest number of physical injuries, hospitalizations, and psychiatric disasters after use. Magic mushrooms are not a new compound, and people are not new to taking them. ​
Madras challenged this notion by citing a 2016 study which analyzed experiences of “bad trips” by psychedelics users. The presentation of this study was important, but misleading. He described how 39% of users rated their trip as an extremely challenging experience. In the same line, Madras said they put themselves or others at risk of physical harm. This is a flawed interpretation of the data and presented it to readers as though 39% of respondents acted violently. Carbonaro et al, reports 11% of respondents putting themselves at physical risk with only 2.6% acting aggressive towards others (4). Even so, 84% of respondents said they greatly benefitted from the experience and endorse psilocybin for others. The authors even reported a positive correlation between the difficulty of the experience and persisting positive outcomes. It is unclear whether these respondents had their experience on their own or under the supervision of a coach/clinical team.
A post about "bad trips", or challenging experiences as psychonauts refer to them, is coming soon.
There are 200+ psychedelic retreat centers around the world; many of which are run by interdisciplinary teams of clinical providers, psychotherapists, and shamanic practitioners (6).
Madras asked how we can standardize protocols for administering psilocybin outside of investigative trials. He stresses the need for an extensive psychotherapy team which can be challenging to create, but clearly not impossible. There are many plant medicine facilitators in the U.S. and globally who have been guiding psychedelic ceremonies. Some of these facilitators have specific retreats or ceremony spaces and others travel to their participants.
As the domestic market for psilocybin sessions expands, the current idea is that participants will receive their treatment in the typical trial-like clinic. This usually looks like a comfortable room that resembles a living room with the participant lying down with a sleep mask. They are in the company of a clinical team. Participants have their experiences rated with questionnaires before, during, and after the session. For many, this clinical setting might be the way to go. They may feel most comfortable consuming psilocybin in this controlled setting.
Why receive the medicine outside of a clinic?
Many of the people who choose psychedelic treatments are those with a holistic view on their mental and physical health. About a quarter of participants in a recent MAPS survey approached psychedelic experiences with spiritual or religious purposes. A major benefit of this nontraditional practice includes personalized, participant designed ceremonies. As we know, the set and setting are most important when taking psychedelics. For participants to have the authority to decide where they have their experience, it nourishes their feelings of comfort. They may choose to have their experience at home or in a natural setting like their yard or a park.
To conclude...
Madras also addressed the strict protocols the FDA may implement for this treatment type moving forward. The intensive training procedures regulated by the FDA are also mentioned. I am all for creating and applying necessary safety measures to protect both participant and facilitator. (I will have a later post analyzing the potential power dynamic issues between participant and facilitator.) However, his language may present a foreboding message to readers who may be interested in a non-clinical coaching dynamic. There are numerous trainings available to facilitators already without federal interference.
The treatment of psychiatric disorders with psilocybin induces intensely personal experiences that are never the same. It seems counterintuitive to try standardizing and sterilizing this care. Various factors can lead to participants not wanting a clinical setting for their experience. The details of how the dose should be administered may also differ for each person if they have religious inspirations. Past psychedelic experiences, feelings towards medical providers, and a person’s spiritual beliefs may change their expectation of the experience.
Thank you for reading. If you are curious about the sources for this post, they are linked here.
1: Burns, J. (2017, May 26). Global survey says Magic Mushrooms are the safest recreational drug. Forbes. Retrieved January 4, 2023, from https://www.forbes.com/sites/janetwburns/2017/05/26/global-survey-says-magic-mushrooms-are-the-safest-recreational-drug/
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2: Harrison, L., & Hughes, A. (1997). Introduction-the validity of self-reported drug use: Improving the accuracy of survey estimates. PsycEXTRA Dataset. https://doi.org/10.1037/e495622006-002
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3: Krebs, T. S., & Johansen, P.-Ø. (2013). Over 30 million psychedelic users in the United States. F1000Research, 2, 98. https://doi.org/10.12688/f1000research.2-98.v1
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4: Carbonaro TM, Bradstreet MP, Barrett FS, et al. Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Journal of Psychopharmacology. 2016;30(12):1268-1278.
5: Levy AG, Scherer AM, Zikmund-Fisher BJ, Larkin K, Barnes GD, Fagerlin A. Prevalence of and Factors Associated With Patient Nondisclosure of Medically Relevant Information to Clinicians. JAMA Netw Open. 2018;1(7):e185293. doi:10.1001/jamanetworkopen.2018.5293