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Spots Global Cancer Trial Database for Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

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Trial Identification

Brief Title: Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

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

Study ID: NCT04522804

Conditions

Cancer

Interventions

Psilocybin

Study Description

Brief 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 25 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Contact Details

Name: Anna Beck, MD

Affiliation: Huntsman Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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