• Trial is one of first to test psychedelic-assisted therapy in combination with individual, as well as group psychotherapeutic support

For patients with cancer who are suffering from major depression, treatment with psilocybin plus individual and group psychological support can significantly relieve depressive symptoms, a clinical trial has found. In a companion study led by Dana-Farber Cancer Institute investigators, trial participants said the treatment experience with psilocybin – a hallucinogenic compound derived from certain mushrooms – created a sense of connection, meaning, and transcendence that aided the healing process.

The trial, described in two papers in the journal Cancer, was one of the first to evaluate the feasibility and efficacy of psilocybin treatment integrated with individual and group support for patients with cancer and depression. It was led by Manish Agrawal, MD, of Sunstone Therapies.

Yvan Beaussant, MD, MSc

"We were very impressed by how many patients benefited from this intervention – and by how much," said Dana-Farber's Yvan Beaussant, MD, MSc, who co-authored one of the new studies in Cancer and led the other. "The trial showed this approach to be viable, safe, and, for many patients, remarkably effective compared to other treatments they had previously tried to treat their depression."

Traditionally, participants in psychedelic agent trials are assigned two therapists, who conduct individual therapy with them before and after the treatment session and are there during the session to support and guide them. In the current trial, participants met with one psychotherapist individually and in small groups before and after treatment. Patients in each group were treated simultaneously in adjacent rooms, with each patient attended by their therapist while two lead therapists observed the sessions by video in a control room.

The arrangement gave investigators an opportunity to explore whether a mix of individual and group psychotherapy – which enables more patients to receive treatment from a single set of therapists – is feasible and beneficial for patients receiving psilocybin for depression. Such information would be critical to scaling up this therapeutic approach for larger numbers of patients. (Psilocybin currently is not approved by the U.S. Food and Drug Administration for clinical use but is being studied in multiple controlled clinical trials.)

The trial enrolled 30 patients who had been diagnosed with cancer and major depression. A week after treatment with a single dose of psilocybin, 50% of participants had experienced a full remission of depressive symptoms and 80% had a positive response to the treatment – a response level sustained for at least eight weeks.

The papers mark one of the first times a major cancer journal has published results of a trial involving a psychedelic drug.

Beaussant interviewed 28 of the participants a few months after the treatment to learn directly from them about the treatment's acceptability and effect on their quality of life. "Even patients who didn't have a major response in terms of reducing depression said they'd gained something valuable from the experience," he says.

"Many described an ongoing transformative impact on their lives and well-being. They felt a greater sense of connection to others, to themselves, and to nature, and a better ability to cope with the difficulties of life with cancer. They reported being gentler with themselves and better able to help themselves on the healing journey they had undertaken."

The group aspect of the treatment was particularly valued. "Having this experience as a group felt reassuring to participants," Beaussant comments. "Especially during the integration phase – the group sessions after treatment with psilocybin – participants appreciated the chance to hear what others had experienced, which in some cases prompted them to explore other dimensions of their own experience."

He adds that when psychedelic plants are used indigenous cultures, it is usually within a group as part of ceremonial rites. From this perspective, the delivery of psilocybin-assisted therapy within a group setting may reflect a norm more than an exception.