drugset / Trial / NCT05585229

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

NCT05585229 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psilocybin-assisted therapy sessions. The study will evaluate the incidence and severity of adverse events during and after treatment, the number of participants who drop out of the study for intervention-related reasons, and the self-reported benefits and harms of the intervention.

Timeline

Start
2025-10-27
Primary completion
2026-08-31
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 25 mg —
Subject Psilocybin Other / unclassified 37.5 mg —