Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
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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
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Study Type | Interventional |
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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 |
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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).
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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.
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Arm/Group Title | Group Therapy Plus Psilocybin | |
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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 |
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Overall Number of Baseline Participants | 18 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | |
59.2 (4.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
Female |
0 0.0%
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Male |
18 100.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
Hispanic or Latino |
1 5.6%
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Not Hispanic or Latino |
17 94.4%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
1 5.6%
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White |
14 77.8%
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More than one race |
3 16.7%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 18 participants |
18 | ||
Year of HIV/AIDS/GRID Diagnosis
[1] Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | |
1988 (4.8) | ||
[1]
Measure Description: HIV = Human immunodeficiency virus; AIDS = Acquired immunodeficiency syndrome; GRID = Gay-related immunodeficiency
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Palliative Performance Scale v2.0
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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.
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Civil status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
Single |
8 44.4%
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Married/Partnered |
8 44.4%
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Divorced/Separated |
2 11.1%
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Education
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
Less than college |
5 27.8%
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College or more |
13 72.2%
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Annual income
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
<$50,000 |
10 55.6%
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≥$50,000 |
8 44.4%
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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 |
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PTSD Checklist-5 (PCL-5) >33/80
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
3 16.7%
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[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.
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Lifetime: People close to you who have died
Median (Inter-Quartile Range) Unit of measure: People |
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Number Analyzed | 18 participants | |
17.5
(7.25 to 30)
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Lifetime: Times used a classic psychedelic
Median (Inter-Quartile Range) Unit of measure: Instances |
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Number Analyzed | 18 participants | |
5
(3 to 23)
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Years since last used a classic psychedelic
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 18 participants | |
20
(1 to 32)
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Name/Title: | Michelle Matvey |
Organization: | UCSF |
Phone: | 4152214810 ext 24117 |
EMail: | michelle.matvey@ucsf.edu |
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 |