Phase 1
N=18
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Distress · Depression · Grief
Bottom Line
View on ClinicalTrials.gov: NCT02950467 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Jan 2021
Primary outcome: Primary: 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 — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Psilocybin (Drug); Modified brief Supportive Expressive Group Therapy (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Joshua Woolley
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
18 | — |
| PRIMARY Subject Recruitment and Retention |
18; 18; 18 | — |
| SECONDARY Change From Baseline in Demoralization Scale-II at End-of-treatment |
-6.67 | — |
| SECONDARY Change From Baseline in Demoralization Scale-II at 3-month Follow-up |
-5.78 | — |
| SECONDARY Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment |
-6.22 | — |
| SECONDARY Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up |
-7.06 | — |
| SECONDARY Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment |
-8.94 | — |
| SECONDARY Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up |
-8.89 | — |
| SECONDARY Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug |
2.61; 1.87; -0.69 | — |
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).
Eligibility Criteria
Inclusion Criterion:
- Older individuals 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.
Data sourced from ClinicalTrials.gov (NCT02950467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.