Trial Outcomes & Findings for Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer (NCT NCT05847686)

Last Updated: 2025-11-05

Results Overview

Defined as the occurrence of participant distress among study participants in the small group during the psilocybin administration session on Day 0 that requires 1:1 facilitator attention that cannot be met by the 4-person facilitation team. The size of small groups of different sizes will vary over the course of the study. Descriptive statistics will be used to analyze and will be tabulated on Day 0 after each group intervention. Backup facilitators will be available when this occurs.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

55 participants

Primary outcome timeframe

At psilocybin administration session on day 0

Results posted on

2025-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Psilocybin, Therapy) Patients receive psilocybin PO and participate in group and individual therapy sessions on trial. Counseling: Participate in therapy visits Psilocybin: Given PO Questionnaire Administration: Ancillary studies
Overall Study STARTED	55
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Psilocybin, Therapy) Patients receive psilocybin PO and participate in group and individual therapy sessions on trial. Counseling: Participate in therapy visits Psilocybin: Given PO Questionnaire Administration: Ancillary studies
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Psilocybin, Therapy) n=52 Participants Patients receive psilocybin PO and participate in group and individual therapy sessions on trial. Counseling: Participate in therapy visits Psilocybin: Given PO Questionnaire Administration: Ancillary studies
Race (NIH/OMB) Asian	1 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants
Race (NIH/OMB) White	49 Participants n=15 Participants
Race (NIH/OMB) More than one race	1 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Hospital Anxiety and Depression Scale	17.5 units on a scale STANDARD_DEVIATION 5.99 • n=15 Participants
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=15 Participants
Age, Categorical >=65 years	4 Participants n=15 Participants
Age, Continuous	53 years n=15 Participants
Sex: Female, Male Female	32 Participants n=15 Participants
Sex: Female, Male Male	20 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants

PRIMARY outcome

Timeframe: At psilocybin administration session on day 0

Outcome measures

Outcome measures
Measure	Treatment (Psilocybin, Therapy) n=52 Participants Patients receive psilocybin PO and participate in group and individual therapy sessions on trial. Counseling: Participate in therapy visits Psilocybin: Given PO Questionnaire Administration: Ancillary studies
Number of Instances of Potentially Unattended Psilocybin-related Distress During Psilocybin Sessions.	0 Events

SECONDARY outcome

Timeframe: From 14 days before the psilocybin session to 28 days (4 weeks) after the psilocybin session

The Hospital Anxiety and Depression Scale (HADS) is a self-administered measure of depression and anxiety. The HADS is not a diagnostic tool, but can screen for anxiety and depression. The HADS has 14 items in total and asks about mood in the past week. Seven items assess depression and seven items assess anxiety. The HADS can be administered repeatedly without impacting on validity. Each item is rated on a 4-point scale and the total provides a score of 0 minimum up to 21 maximum. A higher score indicates higher distress.

Outcome measures

Outcome measures
Measure	Treatment (Psilocybin, Therapy) n=52 Participants Patients receive psilocybin PO and participate in group and individual therapy sessions on trial. Counseling: Participate in therapy visits Psilocybin: Given PO Questionnaire Administration: Ancillary studies
Change in Measured Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS)	-7.29 units on a scale Interval -9.33 to -5.25

Adverse Events

Treatment (Psilocybin, Therapy)

Serious events: 3 serious events

Other events: 30 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Psilocybin, Therapy) n=52 participants at risk Patients receive psilocybin PO and participate in group and individual therapy sessions on trial. Counseling: Participate in therapy visits Psilocybin: Given PO Questionnaire Administration: Ancillary studies
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	3.8% 2/52 • Number of events 2 • 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) dehydration	1.9% 1/52 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	Treatment (Psilocybin, Therapy) n=52 participants at risk Patients receive psilocybin PO and participate in group and individual therapy sessions on trial. Counseling: Participate in therapy visits Psilocybin: Given PO Questionnaire Administration: Ancillary studies
Cardiac disorders hypertension	36.5% 19/52 • Number of events 19 • 6 months
Nervous system disorders anxiety	5.8% 3/52 • Number of events 3 • 6 months
Nervous system disorders headache	3.8% 2/52 • Number of events 2 • 6 months
Gastrointestinal disorders nausea	3.8% 2/52 • Number of events 2 • 6 months
Musculoskeletal and connective tissue disorders shaking	1.9% 1/52 • Number of events 1 • 6 months
Psychiatric disorders malaise	3.8% 2/52 • Number of events 2 • 6 months
Musculoskeletal and connective tissue disorders chest tightness, muscular	1.9% 1/52 • Number of events 1 • 6 months
Nervous system disorders migraine	1.9% 1/52 • Number of events 1 • 6 months

Additional Information

Anthony Back MD

University of Washington

Phone: 2066194367

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place