Psychedelics, a category of substances defined by their hallucinogenic, perception altering properties, have recently been gaining recognition in mainstream medicine for their benefits in treating psychiatric conditions such as addiction,1 Post-Traumatic Stress Disorder (PTSD),2 Obsessive-Compulsive Disorder (OCD),3 depression,4 and anxiety.5 Despite these substances having only recently been recognized for their ability to treat these conditions, psychedelics have been around for much longer and are used in a myriad of different practices and applications around the world.
While some naturally derived psychedelics like ayahuasca and psilocybin, which are commonly known as magic mushrooms, have been around for centuries and used for spiritual ceremonies in Eastern and indigenous cultures. Others like Lysergic acid diethylamide (LSD) and 3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ecstasy, were developed by Western scientists Dr. Alexander Shulgin and Dr. Abert Hofmann in the early 20th century. During the 1960’s, psychedelics became widely used in western culture as recreational drugs known for their “trip” inducing qualities and were associated with the hippie counterculture movement. This increased use of psychedelics led many countries, as well as the United Nations, to label psychedelics as Schedule 1 controlled substances which prevented these drugs from potentially being utilized for medical purposes.
For decades, the interest in or usage of psychedelics was considered taboo due to their illegal status, leading those in search of a remedy for their psychiatric conditions to seek out these substances in other countries in illegal ways.
The Psychedelic Renaissance
However, in recent years there has been a psychedelic renaissance, and although still illegal and labeled as Schedule 1 drugs, these drugs are now being provided in a variety of ways and viewed as more than just a way to “get high.” From a clinical perspective, psychedelics are being evaluated for their therapeutic and medicinal qualities by doctors and therapists, and currently encouraged by the FDA,6 possibly foreshadowing the legalization of these substances for medical usage.
One way in which psychedelic medicines are provided is through “wellness” centers and retreats, advertised as immersive psychedelic experiences leading to growth and well-being. There are also providers known as “sitters” or “guides” who serve as impartial “supervisors,” ensuring a user’s safety or offering necessary guidance during an experience. The Eastern and indigenous ayahuasca and psilocybin experiences still exist today, led by spiritual leaders or shamans who provide an ancient spiritual psychedelic experience.7
Safety, Efficacy, and Ethical Considerations
With the increase in popularity of psychedelic medicines, their safety and efficacy must be established, as well as the outcome of the experience. Based on a review of psychedelic literature, it became evident that while there have been studies conducted which analyze the safety and effectiveness of psychedelics in treating certain psychiatric conditions, there is also a lack of research comparing the different contexts in which psychedelics are taken. In addition to the safety and efficacy considerations, there are ethical issues in some of these settings that can potentially compromise the very vulnerable and impressionable person who is under the influence of psychedelics.
Timothy Leary, a Harvard professor, conducted research on psychedelics at Harvard in the 1960’s and developed the Set and Setting hypothesis which states that the primary determinants of a psychedelic experience are the internal set- intention, expectation, motivation- and the external setting or context, including the presence of a guide or therapist.8 Set and Setting is a primary and crucial aspect of psychedelic treatment. It is therefore imperative that we be conscientious and sensitive to our choice of psychedelic context, specifically where one ingests psychedelics, and evaluate these different environments.
When organizing psychedelic experiences, the shamanistic and religious rituals appear to be the most ethically challenged when compared to the more traditional research contexts. Shamanistic ceremonies typically contain a group of around 10 people, take place for a few consecutive nights, and are led by a shaman or religious leader who has had extensive training in their tradition. During the ceremony, there may be chanting, rhythmic dancing and music, a prayer service or silence. The ceremonies also take place in dim light in order to induce visions. Depending on the medicine used- typically ayahuasca or psilocybin- there is also a purging component, as the medicine causes some users to become sick and vomit. Before and/or after the ceremony, there is usually a preparation and/or review to clarify and frame the users’ experience. The specifics of how the experience is presented is dependent on the tradition of the group leader or shaman, but generally it is framed as accessing metaphysical realms or worlds via spiritual beings and interacting with ‘good” and “bad” spirits. Also, the purging in these ceremonies is framed as the removal of spiritual toxins from the body. This purging, in conjunction with interactions with spirits and the feeling of being separated from one’s physical body in another realm, is part of the process of leaving the user with a healthier and stronger body.9 Some of these religious retreats also contain daytime activities like tai-chi and yoga or fasting, and as their popularity has grown in recent years, more westernized, tourist-attracting versions have been created.
The religious nature of these ceremonies may be viewed as unethical by some, since it seems that the shaman is pushing religious beliefs on the ceremony participants while they are in a vulnerable and impressionable state. However, this spiritual way of framing the experience may have a positive effect, arguably replacing psychotherapy and psychopharmacology, and helping participants to work through and interpret what may be confusing experiences. The ancient traditions of these ceremonies also place emphasis on the significance of set and setting. Their rhythmic beats, which help participants minimize the chance of getting stuck in an unwanted experience, and the presence of a trained leader are both intended to ensure a meaningful and productive experience. While a study exists which analyzes many individual aspects of ayahuasca ceremonies and the experiences and outcomes of participants,10 further research should be conducted to determine if there are any short- or long-term consequences of these religious ceremonies attributed specifically to religious indoctrination.
Risks of Psychedelic Usage
Additional concern may also be due to the lack of a health screen before and after these ceremonies, ensuring that all participants were not at risk for complications during the ceremony or had chances of adverse reactions. While some psychedelics have been shown to be among the safest recreational drugs,11 they do, like all things, have some contraindications and risks. Psychological risks include a bad experience with the potential for developing paranoia, fear, panic, or dysphoria. Distressing effects in modalities such as sensory, somatic, metaphysical, or personal/psychological, can result in the user having disturbing illusions, troubling thoughts, or hyper awareness of physiological processes. These effects, although extremely rare, may lead to dangerous behavior as a result of intensified emotional experience. Although the accuracy of the relationship is still unclear, those who may be suffering with premorbid mental illness may be at increased risk for prolonged psychosis and psychological difficulties post psychedelic session. Additionally, lasting perceptual abnormalities such as Hallucinogen Persisting Perception Disorder (HPPD) or flashbacks to “trip-like” sensations may occur, although incidence is extremely rare. It has also been shown that incidence of these conditions appears to be much lower in contexts with careful screening and preparation.12 In terms of physiological risks, many psychedelics can raise blood pressure and heart rate, therefore those with hypertension should consult with a doctor before using these medicines.13
Seemingly on the other end of the spectrum of ethical psychedelic providers are “sitters'' or “guides.” A part of the underground psychedelic movement, a sitter is anyone who is present for another’s psychedelic experience and serves as an impartial resource for them, ensuring the users safety and helping them through their experience when necessary. In other words, they serve to maintain a set and setting which is conducive to the user having, ideally, an uninterrupted and uninfluenced experience. A guide can be an experienced psychedelics user, a licensed therapist, or someone who has never taken these medicines at all. There are many individuals and groups which offer their own certifications or proposed instructions to follow, however there is no official certification or training that is technically necessary to be a sitter, and no official manual to reference. Using a guide for one’s psychedelic experience may be viewed as the most unadulterated and ethically sound route, as the one-on-one experience and absence of third-party interpretations allow the user to have a completely uninfluenced experience. However, the lack of training of the guide, lack of health screen or follow up, and lack of supplemental therapies or activities must be considered.
Additionally, due to the informal nature of sitters and their use in the underground scene, there is an absence of any data and research for the method.
In terms of available data and detailed protocols, the FDA’s clinical trials on psychedelics are arguably the safest providers of psychedelics. Due to the psychedelic renaissance in recent years, the FDA has been performing clinical trials on the safety and efficacy of various psychedelics to treat different conditions. The exact nature of one’s psychedelic experience in a trial, i.e., the drug being used, the number of sessions, dosage, supplemental activities, accompanying psychotherapy, etc. will differ trial to trial, but common factors include the multiple, spread-out sessions taking place over a few weeks, taking place in quiet, neutral settings, with trained staff and medical personnel available if necessary. Short term follow ups with participants were performed at various points after the session(s) to assess the efficacy of the drug. Health screens are also performed before each trial, however not all trials tested for the same criteria. While most have the exclusion criteria of certain psychological conditions like schizophrenia or bipolar disorder, not all trials perform extensive medical testing to screen for conditions such as hypertension that are possible contraindications for taking certain psychedelics. Additionally, not all trials perform long-term follow ups or post-session health screens to detect any adverse events. That there are trained personnel present measuring outcome data in real time is something that does not take place in the informal settings described above.
Additional psychedelic providers which have become popular are wellness retreats. Located around the United States and across the world, these retreats are marketed towards both first-time as well as experienced psychedelic users. Somewhat of a culmination of the previously mentioned psychedelic providers, they have the greatest diversity in offerings- group or solo sessions, pre- and post- session psychotherapy and integration, and supplementary activities like yoga and massages, allowing for the user to tailor the experience to his or her needs. However, depending on the nature of a specific retreat, the ethical and safety concerns of the previously mentioned distributors may apply as to it well. The staff of these retreats usually have some third-party certifications in and/or experience with psychedelics, but as stated previously, there is no agreed-upon standard for what it means to be qualified in this field. Interestingly, these retreats commonly have medical staff such as psychiatrists and nurses that are very involved with participants, performing detailed health screening and therapies throughout the process to ensure a safe and productive experience.
As more of these psychedelic providers are emerging, and in research settings, the safety and efficacy of these medicines have been proven time and time again, it is imperative that the contexts of these psychedelic providers are studied to ensure ethical, safe, and efficacious delivery of psychedelic medicines to those in search of a treatment for conditions like PTSD, depression, anxiety, for an introspective experience, or even for those just curious about psychedelics. Factors like set and setting, pre- and post- session health screening, training of the provider (the shaman, the sitter or the guide), supplemental therapies, religious agendas, and session follow ups are only some of many factors which must be reviewed.
I am grateful to be participating as a member of a private research group14 that is currently looking to explore the differences between the methodologies of psychedelic providers and laying the groundwork for more research to be done. This research represents but one step towards the possible legalization of psychedelics and provision of help to those suffering with psychiatric conditions. Current medications have unfortunately fallen short of treating psychiatric conditions and psychedelics represent a potential new paradigm for psychopharmacology in the very near future.
References and Notes
1. Jacobson, Roni. “Treating Addiction with Psychedelics.” Scientific American, Scientific American Mind, 1 Jan. 2017, https://www.scientificamerican.com/article/treating-addiction-with-psychedelics/.
2. Mitchell, Jennifer M et al. “MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.” Nature medicine vol. 27,6 (2021): 1025-1033. doi:10.1038/s41591-021-01336-3
3. Moreno, Francisco A et al. “Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder.” The Journal of clinical psychiatry vol. 67,11 (2006): 1735-40. doi:10.4088/jcp.v67n1110
4. Davis, Alan K et al. “Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial.” JAMA psychiatry vol. 78,5 (2021): 481-489. doi:10.1001/jamapsychiatry.2020.3285
5. “Hallucinogenic Drug Psilocybin Eases Existential Anxiety in People with Life-Threatening Cancer - 12/02/2016.” Johns Hopkins Medicine, 2 Dec. 2016,
6. As an example, the FDA is fast tracking MDMA for the treatment of PtSD at the urging of the department of defense-according to Efrem Nulman PhD, of NYU medical center psychedelic research group
7. Ruffell SGD, Netzband N, Tsang W, Davies M, Butler M, Rucker JJH, Tófoli LF, Dempster EL, Young AH and Morgan CJA (2021) Ceremonial Ayahuasca in Amazonian Retreats—Mental Health and Epigenetic Outcomes From a Six-Month Naturalistic Study. Front. Psychiatry 12:687615. doi: 10.3389/fpsyt.2021.687615
8. Hartogsohn, Ido. “Constructing Drug Effects: A History of Set and Setting.” Sage Journals , vol. 3, 1 Jan. 2017, https://doi.org/10.1177/2050324516683325.
9. Metzner, R. “Hallucinogenic drugs and plants in psychotherapy and shamanism.” Journal of psychoactive drugs vol. 30,4 (1998): 333-41.
10. Perkins, Daniel et al. “Influence of Context and Setting on the Mental Health and Wellbeing Outcomes of Ayahuasca Drinkers: Results of a Large International Survey.” Frontiers in pharmacology vol. 12 623979. 21 Apr. 2021, doi:10.3389/fphar.2021.623979
11. Lewis, Tanya. “Johns Hopkins Scientists Give Psychedelics the Serious Treatment.” Scientific American, Scientific American, 16 Jan. 2020, https://www.scientificamerican.com/article/johns-hopkins-scientists-give-psychedelics-the-serious-treatment/.
12. Metzner, R. “Hallucinogenic drugs and plants in psychotherapy and shamanism.” Journal of psychoactive drugs vol. 30,4 (1998): 333-41. doi:10.1080/02791072.1998.10399709
13. Lewis, Tanya. “Johns Hopkins Scientists Give Psychedelics the Serious Treatment.” Scientific American, Scientific American, 16 Jan. 2020, https://www.scientificamerican.com/article/johns-hopkins-scientists-give-psychedelics-the-serious-treatment/.
14. Group members: Dr. Efrem Nulman, Dr. Morgan Campbell, Dr. Emily Goncalves, Chloe Schreiber