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RECRUITING
NCT05585229
PHASE2

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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.

Official title: Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication in Patients With Chronic Pain: an Open-label Feasibility Study

Key Details

Gender

All

Age Range

19 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-10-27

Completion Date

2026-08-31

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DRUG

Psilocybin-assisted Psychotherapy

Participants will complete a 8-week structured psychotherapeutic intervention involving administration of 25mg and 37.5mg PEX010 on two separate occasions.

Locations (1)

University of British Columbia - Okanagan Campus

Kelowna, British Columbia, Canada