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
Study intervention will involve a group of six patients with one therapist per subject for a 1:1 ratio, thus significantly reducing the total number of therapist hours per subject compared to standard individual therapy protocols. Two groups of six will be treated on this trial. After the enrollment and treatment of the first group of six patients, accrual will be placed on hold to ensure subject safety. If stopping rules are not met (Section 11), the next group of six patients will be enrolled and treated on study. The study intervention will include a total of seven group therapy sessions including three 2-hour preparatory sessions, one 8-hour psilocybin session, and one two-hour integration session. The group therapy sessions will occur on a weekly basis, followed one week later by the psilocybin session. The first integration group session will occur 1-2 days following the psilocybin session.NCT Number NCT04522804
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.