Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study
B. Anderson, Alicia Danforth, Prof Robert Daroff, Christopher S. Stauffer, Eve Ekman, Gabrielle Agin-Liebes, Alexander Trope, Matthew Tyler Boden, Prof James Dilley, Jennifer Mitchell, Joshua Woolley
EClinicalMedicine September 24, 2020 DOI: 10.1016/j.eclinm.2020.100538 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label study Pilot study Peer reviewed |
|---|---|
| Population | Older long-term AIDS survivor (OLTAS) self-identified gay men with moderate-to-severe demoralization |
| Intervention | Psilocybin-assisted group therapy |
| Dose | 0.3-0.36 mg/kg po |
| Duration | 8-10 group therapy visits and one psilocybin administration visit; 3-month follow-up |
| Topics | Anxiety Psilocybin |
| Keywords | Adverse effect Depression economics Population Hallucinogen |
| Citations | 271 |
| Registration | NCT02950467 |
| Key points | Psilocybin-assisted group therapy demonstrated feasibility, relative safety, and potential efficacy for reducing demoralization in older long-term AIDS survivor men. |
Abstract
Background: Psilocybin therapy has shown promise as a rapid-acting treatment for depression, anxiety, and demoralization in patients with serious medical illness (e.g., cancer) when paired with individual psychotherapy. This study assessed the safety and feasibility of psilocybin-assisted group therapy for demoralization in older long-term AIDS survivor (OLTAS) men, a population with a high degree of demoralization and traumatic loss.
Methods: Self-identified gay men OLTAS with moderate-to-severe demoralization (Demoralization Scale-II ≥8) were recruited from the community of a major US city for a single-site open-label study of psilocybin-assisted group therapy comprising 8-10 group therapy visits and one psilocybin administration visit (0·3-0·36 mg/kg po). Primary outcomes were rate and severity of adverse events, and participant recruitment and retention. The primary clinical outcome was change in mean demoralization from baseline to end-of-treatment and to 3-month follow-up assessed with a two-way repeated measures ANOVA.
Trial Registration: Clinicaltrials.gov (NCT02950467).
Findings: = 0·47, 90% CI 0·21-0·60).
Interpretation: We demonstrated the feasibility, relative safety, and potential efficacy of psilocybin-assisted group therapy for demoralization in OLTAS. Groups may be an effective and efficient means of delivering psychotherapy pre- and post-psilocybin to patients with complex medical and psychiatric needs.
Funding: Carey Turnbull, Heffter Research Institute, NIMH R25 MH060482, NIH UL1 TR001872, River Styx Foundation, Saisei Foundation, Sarlo Foundation, Stupski Foundation, Usona Institute, US Department of Veterans Affairs (Advanced Neurosciences Fellowship and IK2CX001495).
Comparable studies
Other non-randomized and open-label trials on psilocybin for anxiety, most cited first.