‘Bright’ Yet Cautionary Future for Psychedelics as Evidence-Based Medicine

The future of psychedelic medicine is “bright” with rapidly emerging quality studies currently underway. Clinicians should continue to follow this research before eventually accepting these drugs into their clinical practice, said Rakesh Jain, MD, MPH, in a virtual session today at Sana Symposium.

“We do need to appreciate the potential benefits and risks psychiatry might run with irrational exuberance,” Dr Jain, clinical professor in the Department of Psychiatry at the Texas Tech University Health Sciences Center School of Medicine and co-investigator for Psychedelics and Wellness Studies, told virtual attendees.

Dr Jain examined the current evidence-based research for the 3 best-studied psychedelic medicines using what he called the “gold standard” way to investigate a treatment’s worthiness of an FDA indication. These drugs included ketamine, psilocybin, and MDMA.

Ketamine is both a psychedelic intervention and a medicine as it has both direct biologic effects and gives patients the ‘experience’ of a psychedelic event. Intravenous ketamine has substantial evidence to support its utility in suicide prevention and the treatment of bipolar disorder and depression. It also has a potential role in treating adolescent depression, according to a study Dr Jain briefly presented by Dwyer et al published in the American Journal of Psychiatry.

Dr Jain encouraged listeners to read a recent study by Robin Carhart-Harris, PhD, in the New England Journal of Medicine that compares escitalopram and psilocybin.

“This is going to be one of those central moments in American psychiatry where we look back on time and say that was one of those studies that changed the course of psychiatry,” he said.

Dr Carhart-Harris gave a more in-depth explanation of his study in his own session this morning. The direct, double-blind comparison showed that psilocybin had more of a positive impact on “wellness traits” than escitalopram. The numeric superiority went to psilocybin throughout the study, and patients could better tolerate the side effects of this treatment.

More data on these treatments is on the way, according to Dr Jain. Within the next few months, data from randomized, double-blind, multi-center studies by 2 organizations, Compass Pathways and Usona, will be available regarding the efficacy of psilocybin. Dr Jain told attendees that the message of his session was to “stay tuned,” but he is eager to see where the emerging and promising research leads.

MDMA has promising phase II data in the treatment of post-traumatic stress disorder (PTSD) according to a small study published in The Journal of Psychopharmacology of 28 participants who, by the end, 76% did not meet PTSD disorder criteria. MDMA as a successful treatment for PTSD is also backed by pooled results from 6 phase 2 studies, said Dr Jain. He further expounded on the topic by discussing the first modern-day study on psychedelics published in Nature that investigated the efficacy of MDMA in PTSD.

“Are you noticing a trend here that psychedelic medicine is getting so much attention not just from psychiatry but from medicine and public at large? Nowadays papers regarding psychedelic studies are published in some of the very best journals in the world,” Dr Jain told attendees.

While Dr Jain urged listeners to look forward to the possibilities of psychedelic drugs, he cautioned clinicians to remain diligent.

“I offer you a cautionary tale. The cautionary tale has to do with guarding against excessive and irrational exuberance… psychiatry has a habit of excessively falling in love with, and then hating, and then falling in love with different classes. I say we should stay appropriately optimistic yet avoid excessive exuberance.”

He cited his concerns as stemming from another study by Dr Carhart-Harris that found significant variability in the individual treatment responses of participants who received 2 oral doses of psilocybin despite the mean being promising.

Dr Jain concluded by telling attendees to “hold tight” for the large number of “well conducted,” double-blind, phase 2 and 3 studies that are examining psychedelics.

Reference

Jain R. Evidence supporting psychedelic use in different mental health disease states. Presented at: Sana Symposium; September 17-19, 2021; Virtual.