21 and older, any sex, with Hospice or Psilocybin. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Screened Per Study PeriodPrimary· Through study completion, through 22 months
This measurement will assess enrollment feasibility based on the screening log.
Group
Value
95% CI
Psilocybin- Single Arm
4607
Eligible PopulationPrimary· Through study completion, over 22 months
Number of screened hospice patients who met pre-eligibility criteria and were approached for consent
Group
Value
95% CI
Psilocybin- Single Arm
66
Number of Participants Enrolled Over Study PeriodPrimary· Through study completion, over 22 months
This measurement will assess enrollment feasibility based on the screening log.
Group
Value
95% CI
Psilocybin- Single Arm
15
Average Time From Screening to EnrollmentPrimary· From date of screening until the date of enrollment, assessed up to 12 months
This measurement will assess enrollment feasibility based on the screening log.
Group
Value
95% CI
Psilocybin- Single Arm
36.6
2 – 107
Number of Therapy Sessions Completed by Enrolled ParticipantsPrimary· Through study completion, a period of 22 months
Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5)
Group
Value
95% CI
Psilocybin- Single Arm
9
Psilocybin- Single Arm
1
Psilocybin- Single Arm
3
Psilocybin- Single Arm
1
Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR)Primary· At Week 1 post dosing session
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
Group
Value
95% CI
Psilocybin- Single Arm
90.1
± 11.98
Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14)Secondary· At Baseline, and weeks 1, 3, and 7
The FACIT-Pal-14 is a validated 14-item measure of quality of life in palliative care populations. Items assess physical, emotional, social, and functional well-being over the past 7 days using a 5-point Likert scale (0 = not at all to 4 = very much). Scores are summed to produce a total score ranging from 0 to 56, with higher scores reflecting better quality of life. Subscale scores are not typically reported separately, but can be derived if needed by summing relevant items. The measure is widely used in palliative and supportive care research to evaluate patient-centered outcomes.
Baseline
Group
Value
95% CI
Psilocybin- Single Arm
26.5
22.1 – 30.9
Week 1 (V5)
Group
Value
95% CI
Psilocybin- Single Arm
26.9
22.35 – 31.43
Week 3 (V6a)
Group
Value
95% CI
Psilocybin- Single Arm
30.3
26.84 – 33.82
Week 7 (V6b)
Group
Value
95% CI
Psilocybin- Single Arm
30.8
21.74 – 39.86
Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS)Secondary· At Baseline, and weeks 1, 3, and 7
The PROMIS Pain Interference Scale (8a) is a validated 8-item instrument assessing the extent to which pain hinders engagement in social, emotional, cognitive, and physical activities. Items are rated over the past 7 days on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores range from 8 to 40 and are converted to standardized T-scores (mean = 50, SD = 10) using PROMIS scoring manuals. Higher scores indicate greater interference of pain with daily functioning. The measure is administered only if pain is reported and allows both raw and T-score interpretations to facilitate co
Baseline
Group
Value
95% CI
Psilocybin- Single Arm
24.1
17.58 – 30.64
Week 1 (V5)
Group
Value
95% CI
Psilocybin- Single Arm
24.4
15.66 – 33.2
Week 3 (V6a)
Group
Value
95% CI
Psilocybin- Single Arm
19.7
3.13 – 36.21
Week 7 (V6b)
Group
Value
95% CI
Psilocybin- Single Arm
26.5
11.95 – 41.05
Change in Hospital Anxiety and Depression Scale (HADS A and D) ScoreSecondary· At Baseline, and weeks 1, 3, and 7
It is a self-report questionnaire consisting of 14 items, and subjects rate how they felt during the previous week on a 4-point Likert scale. The HADS consists of an anxiety and depression subscale (0-21 points each), and total scores can range from 0 to 42. Higher scores indicate more severe depression and anxiety.
HADS-A: Baseline
Group
Value
95% CI
Psilocybin- Single Arm
9.7
8.01 – 11.39
HADS-A: Week 1 (V5)
Group
Value
95% CI
Psilocybin- Single Arm
9
5.48 – 12.52
HADS-A: Week 3 (V6a)
Group
Value
95% CI
Psilocybin- Single Arm
5.67
1.13 – 10.2
HADS-A: Week 7 (V6b)
Group
Value
95% CI
Psilocybin- Single Arm
8
4.28 – 11.72
HADS-D: Baseline
Group
Value
95% CI
Psilocybin- Single Arm
10.1
7.54 – 12.66
HADS-D: Week 1 (V5)
Group
Value
95% CI
Psilocybin- Single Arm
9.67
6.41 – 12.93
HADS-D: Week 3 (V6a)
Group
Value
95% CI
Psilocybin- Single Arm
7.83
3.88 – 11.78
HADS-D: Week 7 (V6b)
Group
Value
95% CI
Psilocybin- Single Arm
8.2
2.83 – 13.57
Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) ScoreSecondary· At Baseline, and weeks 1, 3, and 7
The LAP-R Death Acceptance subscale is a validated 8-item measure assessing acceptance of and anxiety about death. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Subscale scores are calculated by summing item responses, yielding a total range of 9 to 56, with higher scores reflecting greater acceptance of death and lower death-related anxiety. The measure is commonly used in palliative care and existential research to evaluate psycho-existential adjustment in serious illness.
Baseline
Group
Value
95% CI
Psilocybin- Single Arm
32.3
24.83 – 39.85
Week 1 (V5)
Group
Value
95% CI
Psilocybin- Single Arm
35
Week 3 (V6a)
Group
Value
95% CI
Psilocybin- Single Arm
34.5
14.77 – 54.23
Challenging Experience Questionnaire (CEQ) ScoreSecondary· Immediately after the intervention, at the end of the dosing day
The CEQ is a validated 26-item instrument assessing psychologically and somatically difficult aspects of psilocybin experiences. It consists of seven subscales: grief (3 items, range 3-15), fear (6 items, range 6-30), death (3 items, range 3-15), insanity (3 items, range 3-15), isolation (3 items, range 3-15), physical distress (3 items, range 3-15), and paranoia (5 items, range 5-25). Items are rated on a 5-point Likert scale (1 = not at all to 5 = extremely). Subscale scores are computed by summing responses within each domain, with higher scores indicating more challenging experiences. A to
Group
Value
95% CI
Psilocybin- Single Arm
36.6
± 20.8
Change in Social Isolation Scale (SIS) ScoreSecondary· At Baseline, and weeks 1, 3, and 7
The PROMIS Social Isolation Scale-6a is a validated 6-item short form that measures perceived social disconnection, including feelings of exclusion, detachment, and lack of belonging. Items are rated on a 5-point Likert scale (1 = never to 5 = always). Raw scores range from 6 to 30 and are converted to standardized T-scores (mean = 50, SD = 10) based on PROMIS scoring guidelines. Higher scores represent greater perceived social isolation. The measure is widely used in psychosocial and palliative care research to assess the impact of illness on social well-being.
Baseline
Group
Value
95% CI
Psilocybin- Single Arm
14.9
12.15 – 17.65
Week 1 (V5)
Group
Value
95% CI
Psilocybin- Single Arm
15.6
12.05 – 19.06
Week 3 (V6a)
Group
Value
95% CI
Psilocybin- Single Arm
13.5
8.96 – 18.04
Week 7 (V6b)
Group
Value
95% CI
Psilocybin- Single Arm
13.4
8.54 – 18.26
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Psilocybin- Single Arm
Serious: 10/15 (67%)
Deaths: 9/15
Serious adverse events (11 terms)
Reaction
System
Psilocybin- Single Arm
Cardiac arrest
Cardiac disorders
—
Ascites
Gastrointestinal disorders
—
Abdominal Pain
Gastrointestinal disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Hip fracture
Musculoskeletal and connective tissue disorders
—
Respiratory, thoracic and mediastinal disorders - Other, specify
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
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
· Phase 2
· not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
· Phase 1, PHASE2
· not yet recruiting
NCT07226232 — Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
· Phase 3
· not yet recruiting
NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or
· Phase 2
· recruiting
NCT07506395 — Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
· Phase 1
· not yet recruiting
Other recruiting trials for Hospice
Currently open trials in the same condition.
NCT07512505 — Remote Vital Sign Monitoring in Palliative Care Patients Using a Wearable ECG Monitor
· recruiting
NCT06835764 — A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
· NA
· active not recruiting
Other Yvan Beaussant, MD, MSci trials
Trials by the same sponsor.
NCT06001749 — Psilocybin in Cancer Pain Study
· Phase 2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yvan Beaussant, MD, MSci
Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04950608.