NCT04522804

Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This pilot project is an open-label trial that will offer psilocybin in a group format to assess the feasibility of offering psilocybin therapy in a group setting with a decreased therapist to subject ratio. 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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Psilocybin	Psilocybin is a classic psychedelic of medium duration that is well-tolerated and has a documented safety and efficacy record that makes it uniquely well-suited to the existential issues that arise in this patient population. Psilocybin has been described as an 'existential medicine' given patient testimonials as to its acute and lasting effects on interpersonal connection, ability to more deeply engage with meaningful activities and relationships, dramatic reductions in fear of death, and a renewed sense of well-being.

Timeline

• Start date: 2021-10-04
• Primary completion: 2022-06-11
• Completion: 2022-12-16
• First posted: 2020-08-21
• Last updated: 2024-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study