Paul Appelbaum, MD: What to Warn Patients When Prescribing Psychedelics in the Future

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In an interview, Paul Appelbaum, MD, discussed issues clinicians will need to bring up to their patients if the FDA approves a psychedelic-assisted therapy.

Right now, psychedelics are still being evaluated on their therapeutic effect and why this effect occurs mechanism-wise. Psychedelics are serotonergic compounds targeting a particular serotonin receptor.1

Despite the current research in psychedelics for psychiatric disorders, psychedelics are still illegal under federal law.

With phase 2 and phase 3 studies underway for MDMA and psilocybin, the US Food and Drug Administration (FDA) can approve the drugs in the foreseeable future.2,3 However, the approval of psychedelic-assisted therapy will present a series of challenges.1 The topic was discussed during the session "Challenges in the Use of Psychedelic Compounds for Psychiatric Treatment" at annual American Psychiatric Association (APA) conference on Sunday, May 5, 2024.

In an interview with HCPLive, Paul Appelbaum, MD, from the director and division of law, ethics, and psychiatry at Columbia University, discussed the issues clinicians may need to discuss with their patients regarding psychedelic-assisted therapy. The first issue he said clinicians should tell their patients is the medication effects which is hard to describe.

“For example, people talk about ego dissolution, or feelings of oceanic boundlessness, or merging with the universe,” Appelbaum said. “These are attempts to capture and essentially ineffable experience, that, nonetheless, we are expecting patients to be able to consent to. Finding ways perhaps by having patients talk with other people who've been through psychedelic experiences themselves, finding ways of communicating that as best we can to patients, prior to consent, I think will be essential.”

However, it goes further than that—Appelbaum explained clinicians will have to tell their patients what they know and do not know about the consequences of psychedelics.

“And that includes at the present time, we don't know the duration of effect, we don't know how likely people would be to respond to repeated administration,” Appelbaum said. “We don't know what the consequences of repeated administration might be over the long term.”

Although clinicians should tell their patients about the consequences of psychedelics, the current clinical trials showed psychedelics are relatively safe and bring very few adverse events.

“What happens when this gets out into the real world, as it were, is something that is some cause for concern, and we need to be cautious about what we need to encourage clinicians to do is to know the database and to respect the database and to use these compounds for clearly indicated indications, but not to branch beyond that before there's an evidence base to support it,” Appelbaum said.

Appelbaum has no relevant disclosures.


  1. Appelbaum, P. Challenges in the Use of Psychedelic Compounds for Psychiatric Treatment. Session presented at: American Psychiatric Association (APA) 2024 Annual Meeting. New York, NY. May 5, 2024.
  2. Derman, C. MDMA-Assisted Therapy for PTSD Is Backed by Positive Data. HCPLive. April 4, 2024. Accessed April 4, 2024.
  3. Derman, C. Adverse Effects of Therapeutic Psilocybin Are “Tolerable” and Resolve in 48 Hours. HCPLive. April 10, 2024. Accessed April 10, 2024.