Each year, Mental Health America publishes a report with rankings based on prevalence of mental illness and rates of access to care across all 50 states and the District of Columbia. The most recent 2023 report presented sobering statistics for the state of Oregon, which ranked #51 for youth and #48 for adults, highlighting that many people in our state are struggling with unmet mental health needs (Ranking Guidelines 2023, n.d.). Undoubtedly, these challenges have been exacerbated by the COVID-19 pandemic over the past 2.5 years. Oregon faces a dire need to find improved solutions to address this crisis, alleviate suffering, and support improved well-being. One such proposed solution is psychedelic-assisted therapy, specifically psilocybin-assisted therapy. 

Psilocybin: A Brief Overview
The term psychedelic, with Greek origins that roughly translate to “mind” (psyche) “manifesting” (delos),was coined in 1956 by English psychiatrist Humphrey Osmond, a pioneer of drug-assisted therapies who conducted research on hallucinogenic drugs as treatment for alcohol dependence (Lowe et al., 2021). Broadly, hallucinogens are psychoactive substances–natural or synthetic–that induce alterations of consciousness, perceptions, cognitions, and emotions, profoundly affecting one’s internal processes and perception of the world around them (Martinotti et al., 2018). Psilocybin, a hallucinogen derived from “magic” mushrooms found in certain regions of South America, Mexico, and the United States, produces an experience characterized by a “sense of new, ineffable knowledge, feelings of unity and connection and encounters with ‘deep’ reality or God” (Smith & Sisti, 2020, p. 807). 

Psilocybin has been used for thousands of years for sacred and ancient traditions among indigenous Mesoamerican cultures to treat both spiritual and physical illness (Van Court et al., 2022). In modern times, psilocybin is illegal in most countries and, since the early 1970s, has been categorized by the United Nations and the United States as a Schedule 1 illegal substance, defined as “drugs with no currently accepted medical use and a high potential for abuse” (Barcenas, 2003; Drug Enforcement Agency, 2021). Recently, psilocybin has gained increased interest for its potential as a mental health treatment and was granted the status of “breakthrough therapy” by the Food and Drug Administration in 2018 and 2019 following promising results from preliminary trials on psilocybin treatment for major depressive disorder and treatment-resistant depression (Lowe et al., 2021). Currently, psilocybin is being researched in association with treatment of a number of conditions, ranging from substance abuse, anxiety, depression, and suicidality to chronic pain, epilepsy, headaches, and cancer-related symptoms (Lowe et al., 2021). 

Oregon Psilocybin Services Act: Knowns and Unknowns
In November 2020, Oregonians voted into law Ballot Measure 109, also known as the Oregon Psilocybin Services Act, making Oregon the first state to establish a regulatory framework for psilocybin services, which are defined as “preparation, administration, and integration sessions with a licensed facilitator” (Oregon Health Authority, n.d.). This legislation directs the Oregon Health Authority (OHA) to license and regulate psilocybin products and services and led to the formation of the Oregon Psilocybin Services (OPS) section, housed under OHA’s Public Health Division’s Center for Health Protection. The ballot measure also established the Oregon Psilocybin Advisory Board, a group of multidisciplinary experts who make recommendations to OHA across five primary domains: Training, Research, Products, Licensing, and Equity. Service centers are expected to open their doors in 2023, depending on the timeline of the four types of new licenses (manufacturing, testing, service centers, and facilitators) that are required to offer services. OPS began receiving applications for training program curriculum approval in June 2022. The first subset of administrative rules relevant to psilocybin products, testing, and training programs was adopted in September 2022, and the remaining rules are scheduled to be adopted later in fall 2022. As December 31st marks the official end of the 2-year development phase, on January 2, 2023, OHA will begin accepting applications for facilitator, service center, manufacturer, and laboratory licenses.

Ethical Considerations: Unique Potential Benefit versus Novel and Unknown Risks
While psilocybin is one of the most widely studied psychedelics, is considered to have one of the most favorable safety profiles of all psychedelics, and boasts promising preliminary clinical evidence for improving certain health outcomes, many unknowns remain about its clinical application (Lowe et al., 2021; Martinotti et al., 2018; Smith & Sisti, 2020; Van Court et al., 2022). These gaps, both at the broader level of scientific research and at the narrower level of statewide rules and regulations, raise important ethical questions. Such questions are relevant to mental health professionals in Oregon, whether viewed from the perspective of a future licensed psilocybin facilitator or as a provider who may be recommending psilocybin services and coordinating care for clients. Broadly, health care providers face questions about what is known about the risks and benefits, what is yet to be learned, and what the implications are for how the state moves forward with implementing legislation. 

Services versus Therapy. The Oregon Psilocybin Act permits OHA to license and regulate psilocybin products and services, and while the measure cites mental health treatment as a primary purpose of this act, the distinction between “service” and “therapy” is significant. This legislation effectively creates a new type of licensed professional (i.e., psilocybin facilitator) that does not fall under a mental health model. Anyone who is over the age of 21; has a high school diploma; is a resident of Oregon; completes the training, exam, background check; and pays the fees can become a licensed psilocybin facilitator. Given that the facilitator training requirements have not been fully outlined or officially adopted, questions remain about how the state will ensure the safety of both the provider and client, and will avoid and minimize harm. Furthermore, additional methods that would have implications for facilitators, such as group administration and microdosing, have not been explicitly addressed but are also not prohibited. What are the minimum skill and training requirements to safely and successfully support a client through a psychedelic experience, and what measures need to be in place to ensure those requirements are consistently met? With the details of Oregon’s Facilitator Code of Ethics ostensibly still being drafted, what ethical training will facilitators receive and in what ethical framework will they be expected to operate? If someone is also a licensed professional in another field (e.g., psychologist, counselor, physician), how would that person navigate identifying and resolving ethical issues that arise during the course of providing psilocybin services if there are conflicting points in the various codes they are legally obligated to uphold? Potential conflicts could include areas such as informed consent, avoiding harm, and boundaries of competence.

Informed Consent. Given the unique nature of a psychedelic experience, informed consent will be a critical part of delivering services in an ethical manner. Smith and Sisti (2020) noted three areas particularly relevant to enhancing informed consent for administering psilocybin in a therapeutic context. First, psilocybin brings about shifts in values and personality that a client may find unwelcoming, and the intensity and extent of these changes is difficult to convey in advance. For example,  a spiritual experience, which is commonly reported with psilocybin use, may present significant challenges for a client who identifies as atheist, and may be impossible to fully imagine beforehand. Second, with novel benefits also come novel risks, some of which are not yet understood. Psilocybin has been found to pose rare but potentially severe mental health risks, including severe anxiety, psychosis, and trauma re-exposure. Clients need to be well-informed about the possibility of experiencing such adverse events. Third, therapeutic touch during the client’s psychedelic experience may be indicated to ensure safety (e.g., holding hands for comfort or guiding an individual to the restroom), and thus presents potential issues with boundaries. Consider the following scenarios: A patient initially consents to be touched but then in the psychedelic state, due to anxiety, rejects being touched. Or a patient initially does not consent to be touched but then becomes agitated and is a safety risk, or becomes distressed and asks to be physically comforted. How does a facilitator navigate determining informed consent and decision-making capacity, and how is that weighed alongside client safety and well-being? What content and process does informed consent need to have to respect, as fully as possible, a client’s right to self-determination throughout participation in psilocybin services?

Client Screening and Outcome Tracking. As Smith and Sisti (2020) aptly stated, “psilocybin is like other novel therapeutic modalities in that ethical challenges arise because knowledge of mechanisms, safety and further benefits is limited and norms about standard practice outside of the research context have yet to emerge” (p. 813). Clinical trials carefully select participants and set stringent eligibility requirements to minimize risk of harm, such as excluding individuals with a history of schizophrenia or heart conditions. In opening psilocybin services to anyone over the age of 21 without the need for referral from a client’s mental health provider, a number of important questions are raised about the screening process for vulnerabilities (i.e., spiritual/religious, trauma, medical) and who will be responsible if a client experiences a harmful or even life-threatening event during a psilocybin session. What kinds of information will be collected in a screener prior to psilocybin administration, and how will facilitators utilize that information given the limited scope of their capacity and access to clients’ medical information? What if a client provides false or incomplete information on a screener, especially since medical personnel will not necessarily be on site? How will client baseline functioning be assessed, and outcomes measured, in order to ensure that we are making well-informed decisions based on evidence, and improving service delivery as we learn more?

Cultural Context. Psilocybin has long played a role in spiritual and religious ceremonies dating back thousands of years across cultures throughout Mesoamerica and continuing contemporarily in Mexican indigenous cultural communities. While practices vary, these ceremonies have typically been carried out at night in a quiet place with the support of an experienced guide or shaman. Additionally, limitations on food, alcohol, medication, and travel are common (Lowe et al., 2021). Given this context, one wonders about the implications of attempting to disentangle the cultural components from the psychedelic components of the psilocybin experience. Can we truly separate the benefits of psilocybin from the cultural fabric of these rituals? What, if anything, is potentially lost or changed by adapting these practices to medicalized applications, and what might be done to avert or mitigate these losses or changes?

Uncharted Territory: Paving the Way Forward
The topics explored above offer only a sampling of the ethical questions raised at this point in the emerging process of implementing the Oregon Psilocybin Services Act. As OHA continues to codify rules and regulations, in tandem with the advisory board, administrative committee, and input from citizens in public listening sessions, we will likely gain clarity from answers and face uncertainty with new questions. Oregon is in the midst of a mental health crisis, and our state desperately needs to find effective, accessible solutions that can help each person live meaningfully and thrive in health. Novel treatments offer unique promise, and they also offer unique challenges. As Oregon paves the way in this uncharted territory, successfully holding and balancing this tension would seem to be a key factor in determining whether ours is a model to follow.

References

Barcenas, G. (2003). Final act of the United Nations Conference for the adoption of a protocol on psychotropic substances. https://www.unodc.org/pdf/convention_1971_en.pdf

Drug Enforcement Administration. (2021). Drug scheduling. https://www.dea.gov/drug-information/drug-scheduling

Lowe, H., Toyang, N., Steele, B., Valentine, H., Grant, J., Ali, A., Ngwa, W., & Gordon, L. (2021). The therapeutic potential of psilocybin. Molecules, 26(10), 2948. https://doi.org/10.3390/molecules26102948

Martinotti, G., Santacroce, R., Pettorruso, M., Montemitro, C., Spano, M. C., Lorusso, M., Di Giannantonio, M., Lerner, A. G. (2018). Hallucinogen persisting perception disorder: Etiology, clinical features, and therapeutic perspectives. Brain Sciences 8(3), 47. https://doi.org/10.3390/brainsci8030047

Oregon Health Authority. (n.d.). Oregon psilocybin: What are psilocybin services? https://sharedsystems.dhsoha.state.or.us/DHSForms/Served/le4226.pdf

Ranking Guidelines 2023. (n.d.). Mental health America. https://www.mhanational.org/issues/2023/ranking-guidelines

Smith, W. R., & Sisti, D. (2020). Ethics and ego dissolution: The case of psilocybin. Journal of Medical Ethics. Advance online publication. https://doi.org/10.1136/medethics-2020-106070

Van Court, R. C., Wiseman, M. S., Meyer, K. W., Ballhorn, D. J., Amses, K. R., Slot, J. C., Dentinger, B. T. M., Garibay-Orijel, R. & Uehling, J. K. (2022). Diversity, biology, and history of psilocybin-containing fungi: Suggestions for research and technological development. Fungal Biology, 126(4), 308-319. https://doi.org/10.1016/j.funbio.2022.01.003.

For more information about the Oregon Psilocybin Services Act, including the adopted rules and details about upcoming meetings and public listening sessions, visit https://www.oregon.gov/oha/ph/preventionwellness/Pages/Oregon-Psilocybin-Services.aspx.