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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02950467
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborators:
Heffter Research Institute
River Styx Foundation
Usona Institute
Stupski Foundation
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Distress
Depression
Grief
Interventions Drug: Psilocybin
Behavioral: Modified brief Supportive Expressive Group Therapy
Enrollment 30
Recruitment Details Participants were recruited from the community 17 July 2017 to 24 August 2018 in the San Francisco Bay Area.
Pre-assignment Details 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.
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description

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

Period Title: Open-label Treatment
Started 18
Completed 18 [1]
Not Completed 0
[1]
1 participant completed study period but missed some visits due to an adverse event (AE).
Period Title: 3-month Follow-up
Started 18
Completed 18 [1]
Not Completed 0
[1]
All participants completed the safety follow-up assessment, but not all completed outcomes measures.
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description

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

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
59.2  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
1
   5.6%
Not Hispanic or Latino
17
  94.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
14
  77.8%
More than one race
3
  16.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
Year of HIV/AIDS/GRID Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
1988  (4.8)
[1]
Measure Description: HIV = Human immunodeficiency virus; AIDS = Acquired immunodeficiency syndrome; GRID = Gay-related immunodeficiency
Palliative Performance Scale v2.0   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
92.8  (11.3)
[1]
Measure Description: This clinician-rated scale reports a total score ranging from 0% (Death) to 100% (Full ambulation, normal activity and work, full self-care, etc). Higher scores indicate better performance.
Civil status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Single
8
  44.4%
Married/Partnered
8
  44.4%
Divorced/Separated
2
  11.1%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Less than college
5
  27.8%
College or more
13
  72.2%
Annual income  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<$50,000
10
  55.6%
≥$50,000
8
  44.4%
Patients meeting current SCID-5/SCID-5-PD diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Generalized anxiety disorder 7
Major depressive disorder 5
Panic disorder 3
Borderline personality disorder 3
No SCID-5/SCID-5-PD diagnosis (of those assessed) 9
[1]
Measure Description:

These diagnostic categories are not mutually exclusive. Patients may meet criteria for more than one diagnosis at one time.

SCID = Structured Clinical Interview for DSM-5 SCID-PD = Structured Clinical Interview for DSM-5 - Personality Disorders DSM-5 = Diagnostic and Statistical Manual of Mental Disorders

PTSD Checklist-5 (PCL-5) >33/80   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
3
  16.7%
[1]
Measure Description: PCL-5 is a self-report checklist used to screen for PTSD symptoms. A score >33/80 indicates a possible diagnosis of current PTSD. Higher scores indicated worse PTSD severity.
Lifetime: People close to you who have died  
Median (Inter-Quartile Range)
Unit of measure:  People
Number Analyzed 18 participants
17.5
(7.25 to 30)
Lifetime: Times used a classic psychedelic  
Median (Inter-Quartile Range)
Unit of measure:  Instances
Number Analyzed 18 participants
5
(3 to 23)
Years since last used a classic psychedelic  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants
20
(1 to 32)
1.Primary Outcome
Title 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
Hide Description

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.

Time Frame Enrollment to 3-month follow up, about 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
2.Primary Outcome
Title Subject Recruitment and Retention
Hide Description Two therapy groups of at least 4 subjects each will complete the study
Time Frame Duration of study, about 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Enrolled
18
 100.0%
Completed Safety Assessment at End-of-treatment
18
 100.0%
Completed Safety Assessment at 3-month follow-up
18
 100.0%
3.Secondary Outcome
Title Change From Baseline in Demoralization Scale-II at End-of-treatment
Hide Description Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.67  (6.5)
4.Secondary Outcome
Title Change From Baseline in Demoralization Scale-II at 3-month Follow-up
Hide Description Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.78  (6.01)
5.Secondary Outcome
Title Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment
Hide Description Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.22  (6.74)
6.Secondary Outcome
Title Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up
Hide Description Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.06  (7.61)
7.Secondary Outcome
Title Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment
Hide Description Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.94  (14.73)
8.Secondary Outcome
Title Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up
Hide Description Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.89  (12.02)
9.Secondary Outcome
Title Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug
Hide Description 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.
Time Frame Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
Positive Bonding (Overall) 2.61  (4.77)
Positive Working (Overall) 1.87  (7.31)
Negative Relationship (Overall) -0.69  (2.70)
10.Other Pre-specified Outcome
Title Change From Baseline in PTSD Checklist 5 at End-of-treatment
Hide Description PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9  (11.47)
11.Other Pre-specified Outcome
Title Change From Baseline in PTSD Checklist 5 at 3-month Follow-up
Hide Description PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.11  (13.81)
12.Other Pre-specified Outcome
Title Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment
Hide Description State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.56  (9.04)
13.Other Pre-specified Outcome
Title Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up
Hide Description State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.06  (13.23)
14.Other Pre-specified Outcome
Title Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment
Hide Description Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.06  (5.5)
15.Other Pre-specified Outcome
Title Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up
Hide Description Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.39  (10.55)
16.Other Pre-specified Outcome
Title Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment
Hide Description HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.83  (5.23)
17.Other Pre-specified Outcome
Title Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up
Hide Description HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat (data capture error for 6 participants)
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.25  (4.47)
18.Other Pre-specified Outcome
Title Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment
Hide Description Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.78  (8.86)
19.Other Pre-specified Outcome
Title Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up
Hide Description Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.33  (7.66)
20.Other Pre-specified Outcome
Title Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment
Hide Description Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.72  (6.85)
21.Other Pre-specified Outcome
Title Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up
Hide Description Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.06  (6.3)
22.Other Pre-specified Outcome
Title Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment
Hide Description 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.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (1.91)
23.Other Pre-specified Outcome
Title Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up
Hide Description 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.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.94  (2.44)
24.Other Pre-specified Outcome
Title Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment
Hide Description Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.
Time Frame Baseline and end-of-treatment (7 weeks duration)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat (one participant did not use antiretrovirals)
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.71  (4.0)
25.Other Pre-specified Outcome
Title Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up
Hide Description Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.
Time Frame Baseline and 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat (one participant did not use antiretrovirals)
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.94  (2.38)
Time Frame From Baseline to 3-month follow-up (5-months post-Baseline)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group Therapy Plus Psilocybin
Hide Arm/Group Description

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

All-Cause Mortality
Group Therapy Plus Psilocybin
Affected / at Risk (%)
Total   0/18 (0.00%)    
Hide Serious Adverse Events
Group Therapy Plus Psilocybin
Affected / at Risk (%) # Events
Total   3/18 (16.67%)    
Gastrointestinal disorders   
Cholecystitis  1  1/18 (5.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Renal cell carcinoma  1  1/18 (5.56%)  1
Psychiatric disorders   
Stimulant-induced psychosis  1  1/18 (5.56%)  1
Suicide attempt  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/18 (5.56%)  1
1
Term from vocabulary, NIH DAIDS v2.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group Therapy Plus Psilocybin
Affected / at Risk (%) # Events
Total   18/18 (100.00%)    
Cardiac disorders   
Tachycardia  1  2/18 (11.11%) 
Gastrointestinal disorders   
Nausea  1  6/18 (33.33%) 
Nausea (post-medication visit)  1  1/18 (5.56%) 
General disorders   
Fatigue (post-medication visit)  1  2/18 (11.11%) 
Nervous system disorders   
Headache  1  5/18 (27.78%) 
Motor agitation / Restlessness  1  4/18 (22.22%) 
Unsteady gait / Ataxia  1  4/18 (22.22%) 
Visual changes (complaint)  1  1/18 (5.56%) 
Headache (post-medication visit)  1  8/18 (44.44%) 
Psychiatric disorders   
Anxiety / Anxiety Exacerbation  1 [1]  8/18 (44.44%) 
Paranoia / Ideas of Reference  1  4/18 (22.22%) 
Thought disorder  1  1/18 (5.56%) 
Insomnia (post-medication visit)  1  2/18 (11.11%) 
Anxiety exacerbation (post-medication visit)  1 [2]  1/18 (5.56%) 
Post-traumatic stress flashback (post-medication visit)  1 [3]  1/18 (5.56%) 
Renal and urinary disorders   
Urinary incontinence  1  1/18 (5.56%) 
Vascular disorders   
Hypertension (severe, asymptomatic)  1  4/18 (22.22%)  4
Hypertension (moderate)  1  8/18 (44.44%)  8
1
Term from vocabulary, NIH DAIDS v2.0
Indicates events were collected by systematic assessment
[1]
(moderate-severe)
[2]
with methamphetamine lapse
[3]
with tinnitus, nausea, panic and insomnia
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle Matvey
Organization: UCSF
Phone: 4152214810 ext 24117
EMail: michelle.matvey@ucsf.edu
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Responsible Party: Joshua Woolley, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02950467    
Other Study ID Numbers: 15-17825
First Submitted: October 26, 2016
First Posted: November 1, 2016
Results First Submitted: September 21, 2020
Results First Posted: January 7, 2021
Last Update Posted: January 7, 2021