The safety of supported psilocybin use in Oregon

Legalized psilocybin services have recently begun in the US state of Oregon after a rule-making process initiated by Ballot Measure 109 (https://sos.oregon.gov/admin/Documents/irr/2020/034text.pdf) in 2020. These services are governed by the Oregon Health Authority, but regulations allow for personal use[1] and rely on facilitators who guide individuals during use. No clinical indication is needed, and guides need not be trained therapists.

We support the decriminalization of psychedelic use and the protection of indigenous practices, but we believe that policies such as Oregon’s are outpacing the scientific evidence about psilocybin’s safety[2]. Experts generally agree that psychedelics can be used safely under medical supervision[3]. However, trials have excluded people at risk for bipolar disorder, psychosis, suicidality and many physical conditions (including diabetes, arrhythmias, seizure disorders and cardiovascular conditions)[4, 5]. Questions remain about how safety data from these trials may generalize outside carefully controlled research contexts; no data exist yet to support regulatory frameworks to ensure safety for psychedelic use.

Perhaps future data may show that psilocybin use is safe without medical oversight. But given current evidence, we advocate oversight by trained mental health professionals and slowing of sweeping legalization efforts[6] while the US Food and Drug Administration’s evaluation and approval processes unfold. Jurisdictions authorizing psychedelic use outside the medical system should develop regulatory approaches that give proper attention to the safety of psychedelics users. In our view, Oregon’s regulations fall short in three areas, exposing service users to potential risks.

First, consensus is emerging that informed consent standards for psychedelics should be more comprehensive than those for most psychoactive medications because the effects of these agents are atypical and often profound, and may be difficult to anticipate without prior experience [7, 8, 9]. Topics that require special attention include the potential for changes to a person’s worldview and values, the role of therapeutic touch, and risks of anxiety, trauma re-exposure, and psychosis or mania in people with underlying conditions or family history[7]. Though high, this consent standard need not be onerous. Many of these topics are discussed routinely in preparatory sessions in research settings[7].

Currently, the Oregon Health Authority’s consent template[10, 11] states that therapeutic touch must be consensual, that there has been a discussion about touch with facilitators, that experiences can be “challenging or uncomfortable” and that psilocybin is “not fully understood”. It also mentions tachycardia, hypertension, “paranoia, perceptual changes, altered thought patterns, reduced inhibitions, recovery of repressed memories and past traumas, and altered perception of time and one’s surroundings”. This understates the potential challenges some service users may experience, the potential risk of psilocybin-induced mania or psychosis, and the possible changes to a person’s fundamental values and life choices.

Second, risk screening is a critical safety measure. At the moment, Oregon only requires service users to answer a few questions about potential risk factors, including those about lithium use, history of diagnosis or treatment for psychosis, and current or past ideation about suicide or harm to others. Minimal physical risks are mentioned in the consent language above, and the additional information form[10] does not specify or explain the relevant medical conditions whose risks have led to their exclusion from clinical trials. Facilitators are merely to encourage people to consult a medical doctor if they have health conditions and to take medications for these conditions.

Third, precautions should be enacted for safety monitoring during and after sessions, but Oregon requires no post-session monitoring[12], although it allows facilitators to conduct post-session integration. Medical providers generally use their reasonable judgment in determining how best to screen and monitor patients given their individual risk profiles. Oregon’s rules endorse a similar approach for facilitators for psilocybin services. They require centers to develop a general safety plan and facilitators to develop individualized plans for each user.

However, Oregon’s training requirements[13] may be insufficient to enable facilitators to individualize screening and monitoring effectively, without medical oversight. Facilitator licensure requires a high-school degree and at least 120 hours of training (including 12 hours on safety and ethics, 4 hours devoted to the underlying science and state of research, and 40 hours of practicum training). This training is unlikely to enable competent judgments regarding subtle psychiatric or physical symptoms characteristic of mania, psychosis, suicidality and cardiovascular disease. Oregon could mandate specific monitoring and emergency protocols, including specific signs and symptoms requiring medical evaluation and availability of clinicians who can be consulted quickly.

A centralized safety data system, like that for vaccination reporting, may better protect Oregonians. Initially, Oregon left data monitoring to individual service centers. However, in June 2023, the state’s controversial SB 303 (https://go.nature.com/48105dy) was signed into law, creating a centralized system to collect safety-related data. SB 303 requires psilocybin service centers to aggregate de-identified information on demographics and reasons for access of clients, as well as the number of individual and group sessions, service denials, adverse reactions, dosing information and the number of psilocybin sessions per client.

Opponents raised concerns[14] about privacy, costs, loss of trust, loss of access and use of data for effectiveness research on non-medical psilocybin services. But independent of SB 303’s motivations or specifics, competent de-identification mitigates privacy concerns, costs could be borne by the state (limiting burdens on service centers) and trust might be better served in the long run by ensuring a well-regulated, safe system. If so, it is unclear why access would be compromised. Finally, monitoring could be restricted to safety data.

Debates about safety considerations like those above are part of a broader debate about whether to regulate psychedelics on ‘the medical model’. Some suggest that Oregon’s model of ‘supported use’ is a clear alternative to a medical or therapeutic model[[15]. They point to the fact that Ballot Measure 109 precluded requiring diagnosis to access psilocybin services and that Oregon regulations prohibit facilitators from engaging in diagnosis and treatment of mental illness[12]. But Ballot Measure 109 also included a goal to ensure “safe, accessible and affordable therapeutic option[s]” for mental health conditions, and the regulations allow facilitators to conduct (and requires them to be trained in) post-session integration, the chief modality of psilocybin-assisted psychotherapy. Thus, both medical and non-medical norms are incorporated into Oregon’s service model.

It might be argued that even safety regulations will risk overmedicalizing psilocybin use. But safety regulations are not unique to medicine and need not curtail reasonable access to a product or service, as evidenced by various non-medical industries, such as airlines and motor vehicle manufacturers. Given the limited evidence on non-medical use, the safety concerns discussed above and ‘psychedelic hype’[6, 16] that may mislead the public about risks and benefits, regulation may actually be more important for supported use than for clinical use. The safety requirements outlined above would enhance psilocybin safety, even for jurisdictions that wish to allow psychedelic use outside of medical settings, while remaining compatible with decriminalization and with indigenous practices and other non-medical uses.