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

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ClinicalTrials.gov Identifier: NCT02950467
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
Heffter Research Institute
River Styx Foundation
Usona Institute
Stupski Foundation
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criterion:

  • Older gay-identified men 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950467


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Joshua Woolley
Heffter Research Institute
River Styx 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

Responsible Party: Joshua Woolley, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02950467     History of Changes
Other Study ID Numbers: 15-17825
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
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
N,N-Dimethyltryptamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists