In an interview, King provided an overview of the history of psychedelic research for psychiatric conditions, where we are now, and what hurdles investigators must address.
Research on psychedelics for psychiatric conditions may have declined after the early 1970s when the US Food and Drug Administration (FDA) required approval for investigational drugs and mandated rigorous trial designs, but now it has returned—although not without its challenges.
Studying psychedelics poses an ethical concern, and investigators in the 1950s and 1960s were able to get away with this easily, hence why the substance received more extensive research during those decades.
In the past, patients were given high doses of LSD and strapped to a bed, only checked on occasionally. Since investigators were afraid the LSD would lead to seizures, they gave the participants Fenelon. Not only was this a poor study design and unethical, but another study found the strapped-to-the-bed method was inferior to patients taking psychedelics in a soothing setting, which resulted in better outcomes.1
Many people believed the creation of the Controlled Substances Act in the Drug Enforcement Administration in 1971 was what halted psychedelic research, but that was not true. It was because of the FDA changes: requiring approval of investigational new drugs, needing permits from the FDA to do the research, and mandating trial design with placebo control.
“It's impossible to blind a psychedelic study,” Franklin King, MD, from Massachusetts General Hospital, told HCPLive. “Some people might contest that, and I don't think that we will ever figure out a way to successfully blind psychedelic studies. Everybody, or the vast majority of participants in placebo-controlled studies with psychedelics, know if they've gotten the psychedelic or the placebo.”
At the annual American Psychiatric Association (APA) conference in New York, King presented the historical evolution of psychedelics in psychiatric treatment, the pharmacological mechanisms of currently researched psychedelics, and the challenges of studying psychedelics in a trial.2
Although studies have moved past stripping patients to a bed and now always have a person in the room with the patient, King said it is important to consider the psychotherapeutic elements before and after the psychedelic session.
“These tend to be things, unfortunately, in modern psychiatric settings that we all know are very important, but we sort of think of them as is, ‘you know, well, it would be nice if the clinic could be more aesthetically pleasing and more soothing, rather than drop ceilings and fluorescent lights, and pleather cushions,’” King said. “It would be nice if our patients who [we] are prescribing medications for could also have quality therapy concurrently. And yet, these things are often very difficult to access, particularly outside of a private practice setting.”
References
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FDA Extends Review for TransCon PTH in Hypoparathyroidism to August 2024
Diabetes Dialogue: 2024 ACP Type 2 Diabetes Recommendations
Febuxostat Use Is Linked to Reduced Risk of Kidney Events for Patients with Gout
Diabetes Dialogue: STEP HFpEF DM and Fair Allocation of Incretin-Based Therapies
Transmasculine Hormone Therapy Could Carry Greater Cardiovascular Risk than Transfeminizing Therapy
Hidradenitits Suppurativa Linked to Increased Risk of Cardiovascular Diseases
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Franklin King, MD: Psychedelic Therapy History, Advances, and Hurdles – MD Magazine
