This open-label pilot trial (n=10) conducted by the University of British Columbia aims to assess the safety and feasibility of an 8-week psilocybin-assisted psychotherapy (25-37.5mg) intervention to facilitate tapering/discontinuation of opioid pain medication in adult patients with chronic pain.
Participants will undergo one or two psilocybin dosing sessions (25mg at week 3 and 37.5mg at week 7) alongside preparatory and integrative therapy sessions. The study will evaluate adverse events, dropout rates, and participant perceptions of the intervention’s benefits and harms.
Primary outcomes include feasibility, acceptability, and safety of psilocybin administration, while secondary outcomes involve changes in prescribed opioid dose over 1, 3, and 6-month follow-up periods.
The study commenced in November 2023 and is expected to conclude in August 2025.
Trial Details
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.Trial Number NCT05585229