RecruitingPhase 2NCT05585229

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

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


Sponsor

University of British Columbia

Enrollment

10 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Psilocybin-assisted Psychotherapy for people with chronic pain and opioid dependence. The study is currently recruiting participants at 1 location. People eligible for this study include aged 19 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin-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

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NCT05585229


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