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NCT04522804 · ClinicalTrials.gov registry record · Early Phase 1
Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT04522804: Completed Early Phase 1 study, sponsored by University of Utah.
NCT04522804 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04522804, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Interventions
- DRUG Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2022-12-16 |
| Phase | Early Phase 1 |
What the finished NCT04522804 record still lists
NCT04522804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Psilocybin is the first listed.
NCT04522804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04522804 about?
NCT04522804 is a clinical study titled "Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer". 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...
What is the current status of trial NCT04522804?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-10-04. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT04522804?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT04522804?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04522804's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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