Ethics in Psychedelic Medicine: Yale Expert Calls for Caution, Consent, and Long-Term Support

Jon Lubecky tried to kill himself five times before a psychedelic drug helped lift his sense of anxiety and dread.

A retired army sergeant, he spoke to “The Today Show” in 2021 about undergoing MDMA-assisted psychotherapy to treat post-traumatic stress disorder (PTSD) following his tours in Iraq. He considered himself cured.

“I’m actually probably better mentally now than I was before I had PTSD,” he said. “This treatment is the reason my son has a father instead of a folded flag.”

Others, though, might experience harm from psychedelics. In 2023, Joseph D. Emerson tried to disable a plane’s engines mid-flight two days after taking psychedelic mushrooms. As he told the story on ABC’s “Good Morning America,” Emerson did not wish to hurt the 83 passengers aboard. He perceived he was in a dream. Because he was unable to distinguish reality from delusion, he thought ending the flight would end his dissociation.

“Psychedelics are in need of regulation and research, but we are broadly seeing trends towards deregulation and defunding of research,” said Lori Bruce, associate director of the Yale Interdisciplinary Center for Bioethics. “And so, we may potentially see more people risking harm, which could create a backlash leading these substances to become overly restricted again instead of creating an environment of reduced risk in which we can promote benefits and reduce harms.”

The center, supported by the Institution for Social and Policy Studies, explores ethical tensions across the globe and within law, policy, public health, clinical settings, and other societal contexts. Recently, it has provided guidance for researchers, institutions, and policymakers to better understand how to ethically navigate a potentially more psychedelic future.

Last summer, the U.S. Food and Administration rejected an application to approve MDMA to help treat PTSD, citing insufficient research. But the legal landscape continues to shift in favor of authorizing psychedelic substances for their potential to offer rapid, powerful, and lasting relief for patients suffering from mental health conditions resistant to existing treatments.

Currently, three states have legalized some form of psychedelic medicine, and 19 others are considering legislation. Six states authorize medical research on the substances, which can include MDMA, also known as ecstasy or molly; psilocybin, the active compound in “magic” mushrooms; and ketamine, a painkiller with hallucinogenic properties. Researchers have found growing evidence that psychedelics — which induce altered states of consciousness — could help treat people struggling with substance use disorders, obsessive-compulsive disorder, treatment-resistant depression, and end-of-life distress.

The push for deregulation offers great promise but also risks.

“We need more public education to help people understand benefits and risks,” said Bruce, who has influenced law and authored policy recommendations on issues including psychedelics, medical aid in dying, infant abandonment boxes, and more. “People need to understand that even if these medicines are deregulated, their effects are not necessarily beneficial or neutral. And even when clinical trials demonstrate successes, the carefully controlled conditions within lab settings are not replicated during recreational usage, meaning the harm profile in the real world may be wider and more variable than what we see in the literature.”

As many as 60% of PTSD patients do not respond to standard prescribed medications or psychotherapy. About a third of patients diagnosed with major depressive disorder are also treatment resistant.

But while psychedelic medicines might help someone address their chronic trauma symptoms and resolve anxiety and depression — sometimes with a single dose — others might experience damage from the treatment itself.

“Psychedelics may also cause trauma, they can cause anxiety, and they can cause depression,” Bruce said. “And we cannot yet distinguish which people are more likely to suffer harms and who will benefit. We also don’t yet know which psychedelics might produce that benefit, because each has different effects.”

Bruce expressed optimism about the increasing number and size of clinical trials involving psychedelics, the increased regulated use at the state level, and decriminalization by states. However, she favors more careful implementation — for both decriminalized use and research — to minimize pitfalls in the process.

Bruce helped write last year’s Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group Consensus Statement, which acknowledged how the unpredictable nature of psychedelic experiences presents unique challenges for obtaining consent from patients.

“Participants in psychedelic research may experience post-trip changes in their lifelong beliefs, such as a sudden disinterest in their religion,” Bruce said. “This may pose difficulties with their families and social units and risk their sense of belonging within their communities.”

In addition, while a substance such as MDMA may open empathic pathways to promote healing, those openings may also leave people vulnerable to financial or physical abuse.

“Risks of psychedelics are not easily navigable through the standard consent process,” she said, “Especially when a research subject feels psychedelics are their last hope.”

Bruce calls for potential participants to come in and talk to researchers to learn more about the nature of psychedelics. She said potential participants should have access to educational videos, virtual reality simulations of a psychedelics experience, and other resources.

“Informed consent is more than just a conversation between one person running the study and a potential subject,” she said. “It should be a back and forth. It shouldn’t be quick.”

In addition, Bruce has expressed concern about the lack of funding for long-term follow-up support sometimes needed after the sessions.

“Most labs lack funding to extend the post-session integration period past a few weeks,” Bruce said. “But long after the study has ended, participants might find themselves experiencing depersonalization, where they feel outside of themselves as though they are watching their life unfold within a movie. Research subjects need access to affordable long-term support services.”

The Hopkins-Oxford group also raised the historical ethical transgressions around psychedelics — including the CIA’s MKUltra experiments with LSD and other drugs on unwitting subjects, abuses of psychiatric patients and prisoners, sexual abuse and boundary violations by session guides, and appropriative practices toward Indigenous communities.

“These past abuses should have a profound role in guiding the procedures we enact today,” Bruce said. “From where we source the substances to how we design the rooms where these session occur, how we handle session recordings, how we choose medications and dosing, how we train guides in consensual touch (a method to help someone during their trip, but one that needs to be done with care and education and safeguards in place) and so much more.”

Bruce also wants physicians to have the appropriate education to properly advise their patients.

“Patients often don’t think they can talk to their doctors about psychedelics, and physicians often lack understanding of the associated risks and benefits,” she said. “But patients should be able to discuss psychedelics with their doctors. And optimally someday gain some advice about if and when and how to use them.”