— Dana-Farber researchers want to find out.
Sixty years after Harvard fired Timothy Leary over his experiments with psychedelic drugs, a hospital affiliated with the university has reopened the door on such research by testing whether hallucinogenic mushrooms can help dying patients face death.
The small trial by researchers at Dana-Farber Cancer Institute’s Psychedelic-Assisted Therapy program is the first to test synthetic psilocybin — the active ingredient in so-called magic mushrooms — in patients in hospice care, according to experts. The patients have cancer, heart disease, and other terminal illnesses and six months or less to live.
The pilot study, which combines a single dose of the psychedelic drug with talk therapy, began in 2022 with the approval of the Food and Drug Administration, and has so far provided psilocybin to eight patients, six of whom have since died. The trial, which is expected to be completed next year after two more patients receive doses, is gauging how well dying patients tolerate the drug and whether it eases their “psychological and existential distress.”
It is only the second study of psychedelics at a Harvard-affiliated institution since the school fired Leary as a psychology lecturer in 1963 for unethical scientific practices, according to researchers. McLean Hospital, a psychiatric teaching hospital of Harvard Medical School, began testing another psychedelic, MDMA, or ecstasy, on cancer patients with anxiety in 2006. But controversy derailed the study, which ended without publication of findings.
Dr. Yvan Beaussant, a palliative care physician at Dana-Farber who is leading the new trial, said he hopes it shows whether psilocybin — used for centuries by the indigenous peoples of Mexico and Central America — along with talk therapy can relieve “demoralization syndrome,” a clinical term for the hopelessness and meaninglessness often experienced by hospice patients.
“These people are facing the most challenging phase of life, dying,” said Beaussant. The eight psilocybin recipients reported varying reactions to the drug, he said, but many later felt a renewed sense of purpose and deeper connections to loved ones. To confirm those benefits, Beaussant said he hopes to launch a larger trial.
Psilocybin, like LSD and other psychedelics, is illegal to buy, possess, or distribute outside of a clinical trial; in 1970 the Nixon administration placed it on the federal government’s list of Schedule One substances, on par with heroin.
But over the past 15 years or so, researchers have tested psilocybin’s potential therapeutic benefits, particularly for people with severe depression and anxiety. Some experts say a growing body of evidence shows that under the right circumstances, psilocybin can improve the mood of patients much faster than traditional psychiatric drugs or talk therapy.
Dr. Roxanne Sholevar, a Dana-Farber psychiatrist and fellow investigator in the psilocybin trial, said she was profoundly moved by the experiences of two terminally ill patients whom she counseled and stayed with during mind-altering trips.
One was a 47-year-old woman who had withdrawn emotionally from her two teenaged children while facing death from pulmonary fibrosis, a progressive lung disease. After taking the drug, the woman reported a mystical experience during which she came upon a primordial river where life began, Sholevar said.
She told Sholevar afterward that she realized that all living things had come from the river, and, like them, she would return to it when she died. That helped allay her depression and anxiety and led her to leave a videotaped message to her children saying she would always be with them.
The other patient, an 81-year-old man who was a devout Catholic, felt life was meaningless because of his impending death, and the death of his wife several years earlier. The man, who also had pulmonary fibrosis, took the capsule containing psilocybin and found himself transported to a dark cathedral where he encountered an “ominous presence” that scared him, Sholevar said.
The researchers summoned a hospice chaplain to comfort him, and the man’s agitation faded. He later told Sholevar that he realized that the purpose of his remaining days was to receive and share God’s love.
“These shifts that I’m describing are the type of things that take years of psychotherapy,” said Sholevar. “I am stunned and reverent and just deeply curious about what we are seeing here and how we can develop this to further enhance its safety and rigor.”
Sholevar and Beaussant said the study could also have a side benefit: repairing the reputation of Timothy Leary.
Leary caused a furor as a lecturer in clinical psychology at Harvard in the early 1960s when he was studying psilocybin, which was legal at the time. Faculty members and administrators complained that he was giving hallucinogens to students and sometimes taking the substances with people he was studying. Leary contended that psychedelic drugs, including LSD, could transform personality and expand human consciousness.
After his firing, Leary went on to urge young people to “turn on, tune in, drop out,” becoming an oracle to hippies and a publicity-seeking crackpot in the eyes of critics. President Richard Nixon allegedly described him as “the most dangerous man in America.”
Still, the psychologist helped to pioneer the importance of “set” ― mindset — and “setting” in the safe use of psychedelic drugs, said Beaussant and Sholevar. That insight is crucial to the team of researchers who guide terminally ill patients through mind-altering trips.
All the participants are in home hospice care provided by Care Dimensions, a hospice provider in Massachusetts. The patients must undergo two counseling sessions at home with a team of two therapists who prepare them to take psilocybin and discuss what they hope to get out of it. Patients are advised to “trust, let go, and be open” to the experience “even if it’s intense or uncomfortable,” Beaussant said.
“People might have blissful experiences,” he said, but others have “very challenging” trips. “Sometimes what might come up is a sense of what you’ve lost, past trauma, painful memories,” he explained. “The idea is not to avoid that.”
Patients undergo two more therapy sessions at home after using the drug to discuss how the experience affected them and how that might change how they live the rest of their lives.
The setting for the trips is the 18-bed Care Dimensions Hospice House, located on 12 wooded acres in Lincoln. Patients typically sit on a recliner or lie in a bed in a room with a patio and a view of landscaped gardens. They wear eye masks to focus their attention inward. Donning headphones, they listen to soothing music on a playlist synched to the onset, peak, and fading effects of the psychedelic experience, which typically lasts about six hours.
At least one researcher stays by the patients’ side, checking their heart rate and blood pressure, both of which typically rise modestly under the influence of psilocybin. It’s critical that patients feel safe.
“The idea of set and setting — we know these factors are really important in shaping the nature of the experience and its potential therapeutic value,” Beaussant said. “That’s work Timothy Leary introduced.”
The notion of rehabilitating Leary’s reputation may seem improbable. But so is the surging interest in the potential benefits of hallucinogens to treat a variety of maladies, from depression to post-traumatic stress disorder to obsessive compulsive disorder — even to irritable bowel syndrome.
“We call it the psychedelic renaissance,” said Rick Doblin, a psychedelic drug activist and founder of the Multidisciplinary Association for Psychedelic Studies, who lives in Belmont. His organization hopes to win FDA approval in mid-2024 of MDMA as part of a treatment for post-traumatic stress disorder.
In recent years, the country’s top medical schools have raced to set up psychedelic research centers, and investors have funneled millions of dollars into start-ups exploring the therapeutic potential of such compounds.
Prominent medical schools supporting psychedelic research include Johns Hopkins, NYU and UCLA.
Massachusetts General Hospital, another Harvard-affiliated teaching hospital, established the Center for the Neuroscience of Psychedelics in 2021 to study the substances. It is planning trials of psychedelics for maladies ranging from rumination to fibromyalgia but hasn’t started testing the compounds yet.
Michael Pollan, author of the best-selling 2018 book “How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence,” was startled to hear about the Dana-Farber study.
“That’s a big deal because of Harvard’s history with psychedelics and the institutional embarrassment over the Timothy Leary episode,” said Pollan, who teaches creative writing at Harvard but is on leave this semester. “I would have thought they’d be the last university in America to venture back into the water.”
Pollan was not surprised, however, by the scientific interest in psychedelics to treat mental disorders.
“The mental health care system is broken,” he said, and clinicians are “desperate for new tools.”
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