This open-label interventional trial (n=12) explored the feasibility of offering psilocybin therapy in a group setting to patients with cancer. The study aimed to decrease the therapist-to-subject ratio, implementing a 1:1 ratio with a group size of six patients.
Two groups of six patients will undergo the trial, with patient safety ensured by halting accrual after the first group is enrolled and treated. The intervention includes seven group therapy sessions, comprising three 2-hour preparatory sessions, one 8-hour psilocybin session, and one two-hour integration session. The sessions will occur weekly, with the first integration group session taking place 1-2 days after the psilocybin session. The main goal is to assess the safety and tolerability of psilocybin in patients with a cancer diagnosis, evaluating adverse events and serious adverse events characterized by severity, duration, relationship to study treatment, seriousness, and type. Furthermore, the feasibility of recruiting, enrolling, and consenting patients with a cancer diagnosis will be assessed.
Trial Details
Trial Number
Sponsors & Collaborators
University of UtahResearch with psychedelics is underway at the University of Utah. At the university, researchers are working with the Usona Institute exploring psilocybin-assisted group therapy in patients with cancer.
Papers
HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with CancerThis open-label study (n=12) investigates the potential of psilocybin-assisted group therapy (PAT) in cancer patients suffering from depression. Participants underwent preparatory sessions, a high-dose (25mg) psilocybin group session, and integration sessions over three weeks, with clinical outcomes measured at baseline, two weeks, and 26 weeks post-intervention. Results show significant decreases in depression symptoms and no serious adverse events, suggesting safety, feasibility, and possible efficacy of the therapy.
Group format psychedelic-assisted therapy interventions: Observations and impressions from the HOPE trial
This qualitative survey (n=10) from patients who underwent psychedelic-assisted therapy (PAT) with psilocybin (25mg) for depression associated with a cancer diagnosis (HOPE trial) provides information on group format PAT, which participants rated highly.