Trial Outcomes & Findings for Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors (NCT NCT02950467)

NCT ID: NCT02950467

Last Updated: 2021-01-07

Results Overview

Full details of adverse event data are in the Adverse Events module of this ClinicalTrials.gov entry. Adverse events were assessed at every study visit by patient interview. During medication visits, adverse events were also assess by vitals sign monitoring, patient self-report, and adverse events observed by clinicians.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Enrollment to 3-month follow up, about 5 months
• Results posted on: 2021-01-07

Participant Flow

Participants were recruited from the community 17 July 2017 to 24 August 2018 in the San Francisco Bay Area.

91 study candidates were screened over the phone, of which 37 were eligible for in-person enrollment evaluations, of which 30 attended an in-person enrollment evaluation and were consented to the study. 18 candidates were found to be eligible for the study, all of whom enrolled in the trial and initiated treatment.

Participant milestones

Measure	Group Therapy Plus Psilocybin Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Open-label Treatment STARTED	18
Open-label Treatment COMPLETED	18
Open-label Treatment NOT COMPLETED	0
3-month Follow-up STARTED	18
3-month Follow-up COMPLETED	18
3-month Follow-up NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

Baseline characteristics by cohort

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Age, Continuous	59.2 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Year of HIV/AIDS/GRID Diagnosis	1988 years STANDARD_DEVIATION 4.8 • n=5 Participants
Palliative Performance Scale v2.0	92.8 units on a scale STANDARD_DEVIATION 11.3 • n=5 Participants
Civil status Single	8 Participants n=5 Participants
Civil status Married/Partnered	8 Participants n=5 Participants
Civil status Divorced/Separated	2 Participants n=5 Participants
Education Less than college	5 Participants n=5 Participants
Education College or more	13 Participants n=5 Participants
Annual income <$50,000	10 Participants n=5 Participants
Annual income ≥$50,000	8 Participants n=5 Participants
Patients meeting current SCID-5/SCID-5-PD diagnosis Generalized anxiety disorder	7 participants n=5 Participants
Patients meeting current SCID-5/SCID-5-PD diagnosis Major depressive disorder	5 participants n=5 Participants
Patients meeting current SCID-5/SCID-5-PD diagnosis Panic disorder	3 participants n=5 Participants
Patients meeting current SCID-5/SCID-5-PD diagnosis Borderline personality disorder	3 participants n=5 Participants
Patients meeting current SCID-5/SCID-5-PD diagnosis No SCID-5/SCID-5-PD diagnosis (of those assessed)	9 participants n=5 Participants
PTSD Checklist-5 (PCL-5) >33/80	3 Participants n=5 Participants
Lifetime: People close to you who have died	17.5 people n=5 Participants
Lifetime: Times used a classic psychedelic	5 instances n=5 Participants
Years since last used a classic psychedelic	20 years n=5 Participants

PRIMARY outcome

Timeframe: Enrollment to 3-month follow up, about 5 months

Full details of adverse event data are in the Adverse Events module of this ClinicalTrials.gov entry.

Adverse events were assessed at every study visit by patient interview. During medication visits, adverse events were also assess by vitals sign monitoring, patient self-report, and adverse events observed by clinicians.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0	18 Participants

PRIMARY outcome

Timeframe: Duration of study, about 24 months

Two therapy groups of at least 4 subjects each will complete the study

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Subject Recruitment and Retention Enrolled	18 Participants
Subject Recruitment and Retention Completed Safety Assessment at End-of-treatment	18 Participants
Subject Recruitment and Retention Completed Safety Assessment at 3-month follow-up	18 Participants

SECONDARY outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Demoralization Scale-II at End-of-treatment	-6.67 units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline and 3-month follow-up

Population: Intent-to-treat analysis

Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Demoralization Scale-II at 3-month Follow-up	-5.78 units on a scale Standard Deviation 6.01

SECONDARY outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment	-6.22 units on a scale Standard Deviation 6.74

SECONDARY outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up	-7.06 units on a scale Standard Deviation 7.61

SECONDARY outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment	-8.94 units on a scale Standard Deviation 14.73

SECONDARY outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up	-8.89 units on a scale Standard Deviation 12.02

SECONDARY outcome

Timeframe: Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.

Population: intent-to-treat

The Group Questionnaire is a self-report measure with three sub-scales that measure Positive Bonding, Positive Working and Negative Relationship dimensions of the relationships at 3 levels: between group members, between group members and group therapists, and between group members and the group as a whole. Each subscale score is calculated by summation of the ratings across all three levels for each subscale. Positive Bonding scores range from 13 to 91 with higher scores indicating a better outcome. Positive Working scores range 8 to 56 with higher scores indicating a better outcome. Negative Relationship scores range 9 to 63 with higher scores indicating worse outcomes.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug Positive Bonding (Overall)	2.61 score on a scale Standard Deviation 4.77
Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug Positive Working (Overall)	1.87 score on a scale Standard Deviation 7.31
Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug Negative Relationship (Overall)	-0.69 score on a scale Standard Deviation 2.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in PTSD Checklist 5 at End-of-treatment	-9 units on a scale Standard Deviation 11.47

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in PTSD Checklist 5 at 3-month Follow-up	-7.11 units on a scale Standard Deviation 13.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment	-5.56 units on a scale Standard Deviation 9.04

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up	1.06 units on a scale Standard Deviation 13.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment	-6.06 units on a scale Standard Deviation 5.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up	-3.39 units on a scale Standard Deviation 10.55

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment	-5.83 units on a scale Standard Deviation 5.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat (data capture error for 6 participants)

HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=12 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up	-4.25 units on a scale Standard Deviation 4.47

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment	-0.78 units on a scale Standard Deviation 8.86

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up	-3.33 units on a scale Standard Deviation 7.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment	-2.72 units on a scale Standard Deviation 6.85

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up	-0.06 units on a scale Standard Deviation 6.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat

Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment	2.0 units on a scale Standard Deviation 1.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat

Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=18 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up	0.94 units on a scale Standard Deviation 2.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end-of-treatment (7 weeks duration)

Population: intent-to-treat (one participant did not use antiretrovirals)

Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=17 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment	-0.71 units on a scale Standard Deviation 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3-month follow-up

Population: intent-to-treat (one participant did not use antiretrovirals)

Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.

Outcome measures

Measure	Group Therapy Plus Psilocybin n=17 Participants Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up	-0.94 units on a scale Standard Deviation 2.38

Adverse Events

Group Therapy Plus Psilocybin

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group Therapy Plus Psilocybin n=18 participants at risk Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	5.6% 1/18 • Number of events 1 • From Baseline to 3-month follow-up (5-months post-Baseline)
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.6% 1/18 • Number of events 1 • From Baseline to 3-month follow-up (5-months post-Baseline)
Psychiatric disorders Stimulant-induced psychosis	5.6% 1/18 • Number of events 1 • From Baseline to 3-month follow-up (5-months post-Baseline)
Psychiatric disorders Suicide attempt	5.6% 1/18 • Number of events 1 • From Baseline to 3-month follow-up (5-months post-Baseline)
Gastrointestinal disorders Cholecystitis	5.6% 1/18 • Number of events 1 • From Baseline to 3-month follow-up (5-months post-Baseline)

Other adverse events

Measure	Group Therapy Plus Psilocybin n=18 participants at risk Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy
Psychiatric disorders Paranoia / Ideas of Reference	22.2% 4/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Nervous system disorders Motor agitation / Restlessness	22.2% 4/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Nervous system disorders Unsteady gait / Ataxia	22.2% 4/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Cardiac disorders Tachycardia	11.1% 2/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Psychiatric disorders Thought disorder	5.6% 1/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Renal and urinary disorders Urinary incontinence	5.6% 1/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Nervous system disorders Visual changes (complaint)	5.6% 1/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Nervous system disorders Headache (post-medication visit)	44.4% 8/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
General disorders Fatigue (post-medication visit)	11.1% 2/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Psychiatric disorders Insomnia (post-medication visit)	11.1% 2/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Psychiatric disorders Anxiety exacerbation (post-medication visit)	5.6% 1/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Psychiatric disorders Post-traumatic stress flashback (post-medication visit)	5.6% 1/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Gastrointestinal disorders Nausea (post-medication visit)	5.6% 1/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Vascular disorders Hypertension (severe, asymptomatic)	22.2% 4/18 • Number of events 4 • From Baseline to 3-month follow-up (5-months post-Baseline)
Vascular disorders Hypertension (moderate)	44.4% 8/18 • Number of events 8 • From Baseline to 3-month follow-up (5-months post-Baseline)
Psychiatric disorders Anxiety / Anxiety Exacerbation	44.4% 8/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Gastrointestinal disorders Nausea	33.3% 6/18 • From Baseline to 3-month follow-up (5-months post-Baseline)
Nervous system disorders Headache	27.8% 5/18 • From Baseline to 3-month follow-up (5-months post-Baseline)

Additional Information

Michelle Matvey

UCSF

Phone: 4152214810

Email: michelle.matvey@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place