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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 : Recruiting
First Posted : November 1, 2016
Last Update Posted : July 11, 2017
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 eight sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients. This study aims to include at least two therapy groups of at least four members each.

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
Estimated Study Start Date : July 6, 2017
Estimated Primary Completion Date : July 30, 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 eight 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
Eight sessions of weekly manualized group therapy




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. Change from baseline in Demoralization Scale-II at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  3. Change from baseline in Demoralization Scale-II at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
  4. Change from baseline in Inventory of Complicated Grief at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  5. Change from baseline in Inventory of Complicated Grief at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
  6. Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  7. Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month follow-up [ Time Frame: Baseline and 3-month follow-up ]
  8. Change in slope of Group Questionnaire pre-psilocybin and post-psilocybin [ Time Frame: Weeks 1, 3, 8 and 10 ]
    Group cohesion measure



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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.
  • Current substance use disorder (other than tobacco).
  • 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


Contacts
Contact: Brian Anderson, MD 415-353-9111 ext 50765 brian.anderson@ucsf.edu
Contact: LISA LIN, BS 415-221-4810 ext 23318 LISA.LIN@UCSF.EDU

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Brian Anderson, MD    415-353-9111 ext 50765    brian.anderson@ucsf.edu   
Contact: Lisa Lin, BA    415-221-4810 ext 23318    Bandlab@ucsf.edu   
Principal Investigator: Joshua D Woolley, MD, PhD         
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: July 11, 2017
Last Verified: July 2017
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