BMJ Open

Psilocybin-assisted therapy for demoralisation in hospice patients: feasibility, safety and preliminary efficacy

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Beaussant, Y., Brennan, C., Kristan, I., Ljuslin, M., Macdonald, D., Mazzola, E., Murphy, M. E., Nigam, K., Rinaldi, A. D., Sager, Z., Sanders, J., Schaefer, K., Sholevar, R., Summer, L., Tulsky, J. A., Waliji-Banglawala, A., Yudilevich-Espinoza, S.

This open-label pilot trial (n=10) found that psilocybin-assisted therapy (25mg) delivered to terminally ill home hospice patients was feasible and safe, significantly reducing demoralisation scores at week 3, though the emotional intensity of the intervention affected acceptability for some participants.

Abstract

Objectives: To assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy (PAT) for demoralisation in terminally ill patients receiving home hospice care.Methods: In this open-label pilot trial, 4607 home hospice patients at a large community hospice were screened over 22 months; 66 were approached, 15 enrolled and 10 received psilocybin. Participants completed two home-based preparation sessions, a single 25 mg oral psilocybin session at an inpatient hospice facility, and two home-based integration sessions. Feasibility was assessed through recruitment, retention and acceptability. Safety was evaluated via adverse event monitoring, and preliminary efficacy was assessed using changes in demoralisation scores and other psychosocial measures.Results: The intervention was well tolerated, with no serious adverse events attributed to psilocybin. At week 3, demoralisation scores significantly decreased (mean reduction: 8.8 points, p=0.0196), despite ongoing clinical decline. Grief- and peace-related themes were prominent during psilocybin sessions. While six participants rated the treatment favourably on the Reaction to Research Participation Questionnaire global evaluation factor, three rated neutral on one or more items, suggesting that the emotional intensity and demands of the intervention may influence acceptability.Conclusion: This study provides initial evidence that PAT can be feasibly and safely integrated into hospice care for terminally ill patients. Further research is needed to optimise delivery and further assess therapeutic potential.