October’s research brings a sharper focus on how psychedelic therapies work in the clinic, what supports their safety, and what current trends reveal about implementation. As ketamine and esketamine move further into routine use, and psilocybin continues to gain clinical ground, these new studies deliver practical lessons for healthcare providers and policymakers planning to scale up psychedelic services.
Five Years of Safety Data from Esketamine in Practice
Five years of post-approval data from over 58,000 esketamine patients in the US, covering nearly 1.5 million supervised sessions, confirm the medication’s established safety profile. Sedation, dissociation, and blood pressure changes remain the most common side effects, reported in 35–41% of sessions, but these effects resolve within 60–70 minutes on average and decrease over time with continued treatment. Crucially, serious adverse events occur in less than 0.2% of sessions, and there is no signal for new risks, abuse, or misuse when administered under structured protocols. These results validate REMS-style safeguards (mandated in-clinic dosing, observation, and systematic reporting) as an effective blueprint for managing risk and supporting insurance reimbursement.
The real-world trajectory of esketamine provides a concrete model for rolling out other psychedelic therapies. Robust infrastructure, encompassing trained staff, facility requirements, ongoing data collection, and clear patient pathways, underpins safe delivery. As providers look to bring other compounds like psilocybin or MDMA into their practices, these lessons are directly transferable. Cost models and staffing plans should account for extended observation, and reimbursement frameworks should be designed with these operational realities in mind.
The Critical Role of Set and Setting in Psilocybin Therapy
Set and setting remain central to patient outcomes, as demonstrated in a qualitative study of psilocybin-assisted therapy for cancer-related depression. In-depth interviews with 28 participants highlight that preparation, a safe environment, and a responsive therapeutic team enable patients to engage deeply with intense experiences, often described as both challenging and transformative. The inclusion of gentle ritual and music, alongside clinical professionalism, fostered trust and meaning. However, the study also warns that vulnerability and heightened suggestibility require strict ethical standards and strong therapist training to avoid harm.
Real-world implications from this psilocybin study are immediate: protocol developers should prioritize not just dosing procedures but also patient preparation, therapist conduct, and post-session integration. Clinical sites must be designed with privacy and comfort in mind, and staff should be trained in both medical and psychological support. For policy leads, this means expanding guidance to include standards for non-pharmacological care, and for investors, the findings reinforce the importance of investing in comprehensive service models, not just drug delivery.
No Evidence for Microdosing Benefits in Controlled Trials
Meanwhile, microdosing remains widely practiced outside formal clinical settings, but new data suggest its benefits are overestimated. Two well-controlled studies, covering 141 participants, found that microdosing psilocybin did not reliably improve cognition, mood, or well-being compared to placebo. Any initial signals in social or cognitive measures vanished after accounting for multiple comparisons, and participants could not reliably distinguish active doses from placebo. The only consistent difference was an increase in bodily sensations, often negative, in the active group. This null result is crucial for clinics and regulators: while high-dose, structured psychedelic therapy is heading toward medical use, microdosing is unlikely to deliver clinical value under current protocols.
For on-the-ground teams, this means focusing resources on established, evidence-based approaches, rather than diverting clinical effort into unproven microdosing regimens. Where patients inquire about microdosing, staff should be prepared to provide evidence-informed responses, explaining both the lack of demonstrated benefit and the importance of participating in structured, monitored care.
Clinical and Policy Implications of October’s Psychedelic Research
Looking ahead, last month’s research supports a cautious but forward-moving path for psychedelic implementation. The evidence base is now robust enough for health systems to design policies around real-world use, but ongoing data collection and quality improvement are essential. Providers should align their protocols with proven safeguards, while policymakers and insurers should fund integrated models that include risk management, staff training, and non-drug supports.
In summary, the newest findings reaffirm that safe and effective psychedelic therapy depends on infrastructure, team training, and ethical conduct as much as on the compounds themselves. Delphi will continue to translate these insights into practical guidance, ensuring that healthcare systems can deliver psychedelic services that are safe, equitable, and grounded in evidence.
