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

• ClinicalTrials.gov Identifier: NCT02950467
• Recruitment Status: Completed
• First Posted: November 1, 2016
• Last Update Posted: February 20, 2020
• Sponsor: Joshua Woolley
• Collaborators: Heffter Research Institute; RiverStyx Foundation; Usona Institute; Stupski Foundation
• Information provided by (Responsible Party): Joshua Woolley, University of California, San Francisco

Study Description

Brief Summary:

The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).

Condition or disease	Intervention/treatment	Phase
Distress; Depression; Grief	Drug: Psilocybin; Behavioral: Modified brief Supportive Expressive Group Therapy	Phase 1

Detailed Description:

This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
• Actual Study Start Date: January 5, 2018
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Psilocybin; One individual oral psilocybin treatment session; Other Names: 4-phosphoryloxy-N,N-dimethyltryptamine; Indocybin; Behavioral: Modified brief Supportive Expressive Group Therapy; Ten sessions of twice-weekly manualized group therapy

Outcome Measures

Primary Outcome Measures :

1. Incidence of 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 [ Time Frame: Enrollment to 3-month follow up, about 6 months ]
2. Subject recruitment and retention [ Time Frame: Duration of study, about 24 months ]
   Two therapy groups of at least 4 subjects each will complete the study

Secondary Outcome Measures :

1. Change from baseline in Demoralization Scale-II at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
   Demoralization measure
2. Change from baseline in Demoralization Scale-II at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
   Demoralization measure
3. Change from baseline in Inventory of Complicated Grief at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
   Complicated Grief measures
4. Change from baseline in Inventory of Complicated Grief at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
   Complicated Grief measures
5. Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
   Depression measure
6. Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
   Depression measure
7. Change in slope of Group Questionnaire pre-psilocybin and post-psilocybin [ Time Frame: Weekly from Baseline to Endpoint (Week 5) ]
   Group cohesion measure

Other Outcome Measures:

1. Change from baseline in PTSD Checklist 5 at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
   PTSD symptom measure
2. Change from baseline in PTSD Checklist 5 at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
   PTSD symptom measure
3. Change from baseline in State-Trait Anxiety Inventory at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
   Anxiety measure
4. Change from baseline in State-Trait Anxiety Inventory at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
   Anxiety measure
5. Change from baseline in HIV and Abuse Related Shame Inventory at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
   Shame measure
6. Change from baseline in HIV and Abuse Related Shame Inventory at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
   Shame measure
7. Change from baseline in Experiences in Closer Relationships-M16 at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
   Measure of attachment anxiety and avoidance
8. Change from baseline in Experiences in Closer Relationships-M16 at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
   Measure of attachment anxiety and avoidance
9. Change from baseline in McGill Quality of Life Questionnaired-Revised Short at endpoint [ Time Frame: Baseline and endpoint (Week 5) ]
   Quality of life measure
10. Change from baseline in McGill Quality of Life Questionnaired-Revised Short at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
    Quality of life measure
11. Change from baseline in Antiretroviral Medication Adherence Scale at endpoint [ Time Frame: Baseline and endpoint (Week 5) ]
    Medication adherence
12. Change from baseline in Antiretroviral Medication Adherence Scale at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
    Medication adherence

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cis-gendered women
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criterion:

• Older women who are long-term AIDS survivors and suffer from moderate-to-severe demoralization.

Exclusion Criteria:

• A physical, neurological or cognitive condition that makes participating in the study unsafe or unfeasible.
• Regular psychotropic medication use.
• Personal or family history of serious mental illness.
• Severe depression requiring immediate standard-of-care treatment.
• Exclusion by the clinical judgment of the study investigators.

Contacts and Locations

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

Joshua Woolley

Heffter Research Institute

RiverStyx Foundation

Usona Institute

Stupski Foundation

Investigators

• Principal Investigator: Joshua Woolley, MD,PhD; University of California, San Francisco
• Study Director: Brian Anderson, MD,MSc; University of California, San Francisco

  Study Documents (Full-Text)

Documents provided by Joshua Woolley, University of California, San Francisco:

Study Protocol and Statistical Analysis Plan: Final protocol  [PDF] February 20, 2019

Informed Consent Form: Final ICF  [PDF] February 20, 2019

Informed Consent Form: ICF for Cohorts 2 and 3  [PDF] April 17, 2018

Study Protocol and Statistical Analysis Plan: Pre-modifications related to enrollment exceptions  [PDF] April 17, 2018

More Information

• Responsible Party: Joshua Woolley, Assistant Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02950467
• Other Study ID Numbers: 15-17825
• First Posted: November 1, 2016
• Last Update Posted: February 20, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joshua Woolley, University of California, San Francisco:

HIV/AIDS; Demoralization; Psilocybin; Group therapy

Additional relevant MeSH terms:

Psilocybin; Depression; Behavioral Symptoms; N,N-Dimethyltryptamine; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Receptor Agonists