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

NCT02950467 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 15-17825
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Distress; Depression; Grief

Keywords

HIV/AIDS; Demoralization; Psilocybin; Group therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced 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

  Full details of adverse event data are in the Adverse Events module of this ClinicalTrials.gov entry. Adverse events were assessed at every study visit by patient interview. During medication visits, adverse events were also assess by vitals sign monitoring, patient self-report, and adverse events observed by clinicians.

  Enrollment to 3-month follow up, about 5 months

• Subject Recruitment and Retention

  Two therapy groups of at least 4 subjects each will complete the study

  Duration of study, about 24 months

Secondary Outcomes (7)

• Change From Baseline in Demoralization Scale-II at End-of-treatment

  Baseline and end-of-treatment (7 weeks duration)

• Change From Baseline in Demoralization Scale-II at 3-month Follow-up

  Baseline and 3-month follow-up

• Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment

  Baseline and end-of-treatment (7 weeks duration)

• Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up

  Baseline and 3-month follow-up

• Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment

  Baseline and end-of-treatment (7 weeks duration)

Other Outcomes (16)

• Change From Baseline in PTSD Checklist 5 at End-of-treatment

  Baseline and end-of-treatment (7 weeks duration)

• Change From Baseline in PTSD Checklist 5 at 3-month Follow-up

  Baseline and 3-month follow-up

• Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment

  Baseline and end-of-treatment (7 weeks duration)

Study Arms (1)

Group therapy plus psilocybin

EXPERIMENTAL

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; Behavioral: Modified brief Supportive Expressive Group Therapy

Interventions

Psilocybin DRUG

One individual oral psilocybin treatment session

Also known as: 4-phosphoryloxy-N,N-dimethyltryptamine, Indocybin

Group therapy plus psilocybin

Modified brief Supportive Expressive Group Therapy BEHAVIORAL

Ten sessions of twice-weekly manualized group therapy

Group therapy plus psilocybin

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joshua Woolley: lead
• Heffter Research Institute: collaborator
• RiverStyx Foundation: collaborator
• Usona Institute: collaborator
• Stupski Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct.

  PMID: 33150319 DERIVED

MeSH Terms

Conditions

Depression; Acquired Immunodeficiency Syndrome

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Results Point of Contact

• Title: Michelle Matvey
• Organization: UCSF

michelle.matvey@ucsf.edu

4152214810

Study Officials

• Joshua Woolley, MD,PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Brian Anderson, MD,MSc

  University of California, San Francisco

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 1, 2016
• Study Start: January 5, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 7, 2021
• Results First Posted: January 7, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)