Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care

NCT04950608 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 21-202
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care.

• The name of the study drug involved in this study is Psilocybin

Conditions

Hospice; Psilocybin; Demoralization; Terminal Illness; Cancer-related Problem/Condition; Psychotherapy; Terminal Cancer; Cancer Terminal

Keywords

Hospice; Psilocybin; Demoralization; Terminal Illness; Cancer related terminal illness; psychotherapy; Terminal Cancer; Cancer Terminal

Outcome Measures

Primary Outcomes (6)

• Number of Participants Screened Per Study Period

  This measurement will assess enrollment feasibility based on the screening log.

  Through study completion, through 22 months

• Eligible Population

  Number of screened hospice patients who met pre-eligibility criteria and were approached for consent

  Through study completion, over 22 months

• Number of Participants Enrolled Over Study Period

  This measurement will assess enrollment feasibility based on the screening log.

  Through study completion, over 22 months

• Average Time From Screening to Enrollment

  This measurement will assess enrollment feasibility based on the screening log.

  From date of screening until the date of enrollment, assessed up to 12 months

• Number of Therapy Sessions Completed by Enrolled Participants

  Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5)

  Through study completion, a period of 22 months

• Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR)

  The RRPQ-R is a validated 23-item instrument designed to assess participants' experiences and perceptions of research participation. It comprises five subscales: participation (7 items, range 7-35), personal benefit (5 items, range 5-25), emotional reactions (6 items, range 6-30), perceived drawbacks (3 items, range 3-15), and global evaluation (2 items, range 2-10). Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores on participation, personal benefit, and global evaluation indicate more positive perceptions, while higher scores on emotional reactions and perceived drawbacks reflect greater negative emotional or practical impact. A total score can be calculated by summing across all items (range 23-115), with higher scores reflecting more favorable overall experiences of research participation.

  At Week 1 post dosing session

Secondary Outcomes (9)

• Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14)

  At Baseline, and weeks 1, 3, and 7

• Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS)

  At Baseline, and weeks 1, 3, and 7

• Change in Hospital Anxiety and Depression Scale (HADS A and D) Score

  At Baseline, and weeks 1, 3, and 7

• Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score

  At Baseline, and weeks 1, 3, and 7

• Challenging Experience Questionnaire (CEQ) Score

  Immediately after the intervention, at the end of the dosing day

Study Arms (1)

PATH

EXPERIMENTAL

The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions

Drug: Psilocybin; Behavioral: Psychotherapy

Interventions

Psilocybin DRUG

Oral, single administration, dosage 25 mg orally

PATH

Psychotherapy BEHAVIORAL

The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions

PATH

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients enrolled in hospice care at home
• Age ≥ 21 years.

You may not qualify if:

• Palliative Performance Scale (PPS) ≥ 50 % (see Appendix A)
• Moderate-to-severe demoralization as measured by Demoralization Scale-II ≥ 8
• Significant other or other caregiver present at home the night of study drug administration
• No driving for 24 hours following study drug administration.
• English proficiency
• Ability to understand and the willingness to sign a written informed consent document.
• Psilocybin is very likely to have no genotoxic effects. One study that directly focused on the mutagenic potential of psilocybin did not found this type of toxicity. However, due to the lack of clinical and non-clinical studies on the effects of psilocybin on the developing human fetus, women and men of child-bearing potential and who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.
• Current General Inpatient (GIP) hospice status
• Patients currently receiving chemotherapy
• Condition impairing oral intake or digestive absorption
• Presence of a delirium diagnosed by the CAM
• Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on item 5 on the C-SSRS within the past month or at V0
• Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history
• Patients with first-degree relatives with schizophrenia or bipolar disorder
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin

Sponsors & Collaborators

• Oppenheimer Family Psychosocial Oncology and Palliative Care Research Grants: collaborator
• Carey and Claudia Turnbull Family Foundation: collaborator
• Heffter Research Institute: collaborator
• George Sarlo Foundation: collaborator
• RiverStyx Foundation: collaborator
• Council on Spiritual Practices Fund at the San Francisco Foundation: collaborator
• Nikean Foundation: collaborator
• Jack Smith: collaborator
• Yvan Beaussant, MD, MSci: lead
• Usona Institute: collaborator

Study Sites (1)

Care Dimensions

Danvers, Massachusetts, 01923, United States

Location

MeSH Terms

Interventions

Psilocybin; Psychotherapy

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Behavioral Disciplines and Activities

Limitations and Caveats

This pilot study is limited by its small sample size, lack of control group, and homogeneous participant demographics. Its single-site design further limits generalizability. Additionally, due to the rapidly evolving clinical condition of participants, missing data at later time points limited our ability to assess medium to long-term outcomes.

Results Point of Contact

• Title: Dr. Yvan Beaussant
• Organization: Dana-Farber Cancer Institute

patresearch@dfci.harvard.edu

617-582-9318

Study Officials

• Yvan Beaussant, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 6, 2021
• Study Start: March 9, 2022
• Primary Completion: July 27, 2024
• Study Completion: December 31, 2025
• Last Updated: February 17, 2026
• Results First Posted: September 2, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)