Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC)

OPENING SOON

Sunstone Therapies is recruiting participants for a Phase 2 multi-center, parallel group, randomized controlled study to evaluate the efficacy of psilocybin therapy in treating demoralization in adult patients at the end of life (≤2 years life expectancy).

Introduction and Rationale for Study

Demoralization is an existential distress characterized by a sense of helplessness, hopelessness, and loss of meaning and purpose in life and is highly prevalent in individuals with serious medical illnesses. Demoralization has a strong association with suicidal ideation and major depressive disorder.
Currently, there is a lack of effective, rapid, and evidence-based interventions that improve demoralization and well-being in patients near the end of life. Psilocybin therapy has shown promise as an intervention for existential distress in end-of-life palliative care patients specifically regarding meaning-making.

Purpose and Description

This study will implement a multi-center, parallel group, and randomized controlled design to 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).

Additionally, this study will investigate the efficacy of psilocybin therapy for addressing depression and
anxiety symptoms, quality of life and spiritual wellbeing.

The therapy model used throughout the study is
Meaning and Purpose Therapy (modified for psilocybin)
(P-MaP).


The study involves the following participant activities between a 2 to 4 month period:

  • One (1) Baseline Session
  • Up to three (3) Preparation sessions
  • One (1) Dosing Session
  • Two (2) Existential Behavioral Intervention
  • Three (3) Assessment Sessions

Participants in the control group may be eligible to
cross over into an open-label psilocybin session

Important Considerations

  • The study’s procedures and therapy are at no cost to the participant.
  • Eligible participants will be randomized 1:1 to receive a single moderate-to-high dose of psilocybin or low-moderate dose of oral ketamine (active control). Participants, research staff, and therapists are all blinded.
  • Study drugs will be administered in a safe setting with continuous support from trained and experienced therapists. The support includes careful preparation before the experience and processing after the experience. Psychedelic effects are typically temporary, and safety is continually monitored.
  • Eligible participants will taper or discontinue all antidepressants as part of their participation in the study as applicable and with physician oversight. Participants MUST NOT discontinue ANY medication without the physician’s approval. If necessary, the study physician will consult with patients’ providers.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial.
  • Risks to participation will be reviewed extensively during the screening and informed consent process.
  • All in person visits take place at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.

To inquire about participation in the PT2PC study, apply below:

Apply For The Study

For more information about the study: https://clinicaltrials.gov/study/NCT05403086?term=psilocybin%20palliative&rank=1