drugset / Trial / NCT05585229
Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 25 mg | — |
| Subject | Psilocybin | Other / unclassified | 37.5 mg | — |