Open-label, single-group Phase I study (n≈11) assessing safety, feasibility, and acceptability of a single 25 mg oral psilocybin dose with supportive psychotherapy and multidisciplinary palliative care in cancer survivors with demoralization and chronic pain.
This Phase I single-group study evaluates safety, feasibility, and acceptability of a single 25 mg oral psilocybin administration provided with supportive psychotherapy and multidisciplinary palliative care in adult cancer survivors living with demoralization and chronic pain; participants are observed after dosing and followed to 3.5 months.
Exploratory outcomes include changes in demoralization, anxiety, depression, quality of life, pain, mysticism, post-traumatic growth, social isolation, and psychosocial functioning; assessments occur across multiple post-dose visits.
Single-group administration of psilocybin with supportive psychotherapy and multidisciplinary palliative care; observation and scheduled follow-ups.
Single oral dose administered on day 14 with post-dose observation.
Supportive psychotherapy provided alongside dosing and follow-up visits.
Quality-of-life assessments and questionnaire administration as ancillary measures.