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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 : May 21, 2019
Sponsor:
Collaborators:
Heffter Research Institute
River Styx Foundation
Usona Institute
Stupski Foundation
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 26, 2016
First Posted Date  ICMJE November 1, 2016
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE January 5, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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 ]
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
Incidence of treatment-related adverse events as assessed by DAIDS 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 ]
Change History Complete list of historical versions of study NCT02950467 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Change from baseline in Demoralization Scale-II at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
    Demoralization measure
  • Change from baseline in Demoralization Scale-II at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
    Demoralization measure
  • Change from baseline in Inventory of Complicated Grief at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
    Complicated Grief measures
  • Change from baseline in Inventory of Complicated Grief at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
    Complicated Grief measures
  • Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
    Depression measure
  • 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
  • Change in slope of Group Questionnaire pre-psilocybin and post-psilocybin [ Time Frame: Weekly from Baseline to Endpoint (Week 5) ]
    Group cohesion measure
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • 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
  • Change from baseline in Demoralization Scale-II at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  • Change from baseline in Demoralization Scale-II at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
  • Change from baseline in Inventory of Complicated Grief at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  • Change from baseline in Inventory of Complicated Grief at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
  • Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  • Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
  • Change in slope of Group Questionnaire pre-psilocybin and post-psilocybin [ Time Frame: Group therapy sessions 1, 3, 6 and 8 ]
    Group cohesion measure
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2018)
  • Change from baseline in PTSD Checklist 5 at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
    PTSD symptom measure
  • Change from baseline in PTSD Checklist 5 at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
    PTSD symptom measure
  • Change from baseline in State-Trait Anxiety Inventory at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
    Anxiety measure
  • Change from baseline in State-Trait Anxiety Inventory at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
    Anxiety measure
  • Change from baseline in HIV and Abuse Related Shame Inventory at endpoint [ Time Frame: Baseline and endpoint (6 weeks duration) ]
    Shame measure
  • 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
  • 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
  • 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
  • Change from baseline in McGill Quality of Life Questionnaired-Revised Short at endpoint [ Time Frame: Baseline and endpoint (Week 5) ]
    Quality of life measure
  • 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
  • Change from baseline in Antiretroviral Medication Adherence Scale at endpoint [ Time Frame: Baseline and endpoint (Week 5) ]
    Medication adherence
  • Change from baseline in Antiretroviral Medication Adherence Scale at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
    Medication adherence
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Official Title  ICMJE Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Distress
  • Depression
  • Grief
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Psilocybin
  • Behavioral: Modified brief Supportive Expressive Group Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02950467
Other Study ID Numbers  ICMJE 15-17825
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joshua Woolley, University of California, San Francisco
Study Sponsor  ICMJE Joshua Woolley
Collaborators  ICMJE
  • Heffter Research Institute
  • River Styx Foundation
  • Usona Institute
  • Stupski Foundation
Investigators  ICMJE
Principal Investigator: Joshua Woolley, MD,PhD University of California, San Francisco
Study Director: Brian Anderson, MD,MSc University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP