Pragmatic Trial of Psilocybin Therapy in Palliative Care

Psilocybin

Brief Summary

This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).

Intervention / Treatment

  • Drug: Psilocybin
  • Drug: Ketamine

Condition or Disease

  • Demoralization

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 100 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Oct 01, 2022
Primary Completion: Dec 31, 2024
Completion Date: Dec 31, 2026
Study First Posted: Jun 03, 2022
Last Updated: Jun 03, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

After providing written informed consent, participants deemed eligible for this trial will be randomized to a brief course of talk therapy plus 1 dose of oral psilocybin vs the same brief course of talk therapy plus 1 dose of oral ketamine (the active control). Participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. After completing the study, participants will have the option of being told which study drug they took (aka, "unblinded"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT05403086
Acronym: PT2PC
Other IDs: 21-008459
Study URL: https://ClinicalTrials.gov/show/NCT05403086
Last updated: Jun 17, 2022