Psychedelic Medicine Could Fill Care Gap in Psychiatric Care

There is a tremendous need for new and better psychiatric treatment, Gregory A. Fonzo, PhD, assistant professor and co-director at the Center for Psychedelic Research and Therapy at The University of Texas at Austin Dell Medical School, said in a session at the American Association of Psychiatric Pharmacists Conference 2024.

In the session, Fonzo said two-thirds of individuals with depression will not reach remission with initial treatment, and another third of these patients will not reach remission after 4 consecutive treatments. Furthermore, approximately 50% to 75% of patients with posttraumatic stress disorder (PTSD) will not respond to first line treatment options.

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“There are substantive differences between the psychedelic-assisted therapy model and the typical psychiatric care model,” Fonzo said in the session.

Fonzo said that there are 2 classes of psychedelics: classic psychedelics, such as psilocybin, LSD, and mescaline, and empathogen/entactogen psychedelics, such as MDMA. Classic psychedelics primarily bind to the 5HT-2A receptor, with the drug’s intensity subject to the effects of this receptor. They also bind to other serotonin receptors, including H1, alpha adrenergic 2A and 2B, and dopamine receptors. According to Fonzo, MDMA works differently, with the brain releasing 5-HT, and MDMA weakly binds to the 5HT-2A receptor, which causes individuals to not typically experience hallucinations.

Additionally, Fonzo said the effects of psychedelic medicine can vary greatly across patients and even within the same patient, depending on environment, dosing, and other factors. When administering psychedelic medication, it is important for the patient to be internally ready, including their mood, their expectations, and their intentions, as well as to have their setting (social, physical, and cultural environment) optimized for treatment.

Fonzo said there are 3 different types of sessions for psychedelic-assisted treatment: a preparatory session, a dosing session, and an integration session.

The preparatory phase typically takes 4 to 8 hours, over 1 to 4 sessions. It includes informed consent and is used to build a patient-therapist rapport. Patients and therapists will also discuss lived experiences with their mental health condition, effects of psychedelic medicine, how to best navigate the experience, and how to deal with difficult experiences. Patients are sometimes introduced to the dosing room for familiarity, according to Fonzo.

The dosing session takes place over 1 full day, typically over the course of 6 to 8 hours, according to Fonzo. The drug is administered in a comfortable living room-like setting with a therapist present, and headphones and eyeshades are available for the patients. The therapist employs a non-directive and supportive approach, including empathy and reassurance to manage anxiety or other distressing emotions. Therapists could also use therapeutic touch, which must be discussed beforehand and utilized appropriately with consent, according to Fonzo.

Finally, patients undergo the integration phase, with 1 or more sessions typically starting the day after dosing. During this phase, patients and therapists discuss the experience from the dosing session.

Fonzo said there are substantial differences between psychiatric-assisted therapy and typical psychiatric pharmacotherapy, including the acute and chronic dosing schedules, the setting of administration, and the time to onset of each medication.

But while research has shown benefits to psychedelic medication, there are a lot of legal hurdles and ethical dilemmas associated with psychedelic medication. One significant challenge is lingering stigma and misinformation stemming from the counterculture movements in the 1960s.

“Psychedelics have a lot of baggage,” Fonzo said in the session. “This kind of puts this unique burden on researchers to really try to get us to be very open and transparent about the type of studies we've been doing.”

Another ethical dilemma Fonzo mentioned was patient vulnerability. Psychedelics can lower a patient’s defenses, which can result in vulnerability for abuse and a reduced capacity for critical discernment. Furthermore, the pro-social effects of MDMA could lead to inappropriate behavior between study patients and study staff, Fonzo said. He added that there have been times at spiritual retreats that patients were taken advantage of, highlighting the importance of educated health care providers and safe environments.

Other barriers to psychedelics could include affordability and availability, with Fonzo estimating that treatment could cost approximately $12,000 for a single course. This could mean that many who could benefit from treatment might not be able to afford the treatment. Further, there are no current guidelines and regulatory bodies for psychedelic medication, Fonzo said. Another challenge could be the complexity of real-world patients, who could have comorbid conditions such as bipolar disorder or schizophrenia.

Fonzo also acknowledged legal hurdles for schedule I drugs. When conducting research, an application to the Drug Enforcement Administration (DEA) is required. A secure storage facility, including either a 750-plus pound safe or a safe that is bolted to the floor or wall, is needed to ensure drug safety and limited access to the drug in the storage room.

Currently, MDMA-assisted therapy is undergoing review for approval by the FDA. The approval would reschedule the compound on the federal level, but according to Fonzo, the DEA could choose not to comply. In 1984, the DEA scheduled MDMA as a schedule I drug, despite a judge recommending the drug as a schedule III. The schedule I registration means a drug has no accepted medical benefit.

Furthermore, another legal huddle could be state legalization because states’ decisions could conflict with federal scheduling. Fonzo added that even without approval, psychedelics can remain experimental treatments.

Fonzo also addressed some ways to address these challenges, such as having 1 therapist per patient and video monitoring, with a “floating” therapist who could provide relief for the primary therapist as needed and provide additional monitoring of the patient. Small group facilitation was also suggested, but the biggest way to address challenges would be to create and use standardized psychoeducation materials for those who are offering psychological support with psychedelics.

Additionally, Fonzo said safety would be improved for patients if a drug were developed to abort the psychedelic experience as needed for patients. He also added that there has been research designed to develop new molecules for therapeutics that have similar effects of psychedelics without altering a patient’s state of consciousness. Fonzo said there is active research in this area.

Reference

Fonzo GA. Psychedelics: Ethics and Real World Applications. American Association of Psychiatric Pharmacists Conference 2024; Orlando, Florida; April 7-10, 2024.