Psychedelic medicines such as psilocybin have grabbed attention from the public and medical community as a much-needed solution to treating major depressive disorder and an array of other conditions. But could rising media coverage and commercial interest in psychedelics outpace the development of guidelines required for safely integrating psilocybin into clinical practice?

In a consensus statement published recently in eClinicalMedicine (part of The Lancet Discovery Science), a panel of experts — including Johns Hopkins faculty and trainees from Psychiatry and Behavioral Sciences* — advocates for a balanced approach “that prioritizes rigorous scientific standards while considering the urgency of the need for better treatment options.” Among the panel’s recommendations:

Expand scientifically rigorous studies

To ensure research is driven by public health needs, not just market incentives, it’s critical to broaden funding sources beyond private companies and philanthropy to include major funding bodies such as the National Institutes of Health, the authors note. They advocate moving from small, single-site studies to large, multi-center trials that allow for data-sharing and big data approaches. Critically, design of large-scale studies should evaluate the relative contributions of drug vs. associated psychotherapy as well as the interactions between drug and psychotherapy — which “are closely intertwined and not yet separable based on the current literature,” they write.

Noting that more than 80% of participants in psychedelic trials have been white, the authors call for involving participants from diverse backgrounds and marginalized communities. And they advocate for more robust longitudinal studies evaluating potential harms of short-term and long-term psilocybin administration and potential risk factors for adverse events — as well as standardized monitoring systems to track adverse events related to psilocybin use in a clinical context.

Ensure that medical implementation is ethically grounded

The use of psychedelics poses a number of unique ethical considerations not seen in conventional treatments, the authors note. Given that patients experience altered states of consciousness, potentially making them more open to the power of suggestion and even potential boundary violations on the part of providers, psychedelics “require a reassessment of the traditional informed consent process in medicine.”

Develop standardized education and training opportunities

While providing broad and safe access to psychedelics will require well-informed providers, to date, “standardized evaluation of provider competence is nonexistent,” the authors note. To address critical gaps, they recommend developing a national standardized curriculum for clinical trainees (psychiatry residents, nursing, pharmacy, medicine, psychology and social workers). They also call for developing advanced fellowship and internships in psychedelic medicine and research, and for continuing education opportunities aimed at providers in current practice.

*Megan Hosein, Matthew Reid, Sarah Walser, David Yaden, Zachary Cordner, Frederick Barrett.

Read the consensus statement in full: Bit.ly/JHMConsensus