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Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 4, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Feb 28, 2025 to Aug 31, 2026
    • Start date changed from estimate of Nov 1, 2023 to Oct 27, 2025
    • Study completion date: Aug 31, 2025 to Aug 31, 2026
    • Site details revised
  2. Notable Primary completion date: Jun 15, 2024 to Feb 28, 2025v3 Show 5 more changesShow less
    • Start date: Jun 15, 2023 to Nov 1, 2023
    • Study completion date: Jun 15, 2024 to Aug 31, 2025
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 1 word
    • Collaborators expanded, about 2 words
  3. Notable Primary and study completion dates: Dec 15, 2023 to Jun 15, 2024
    • Start date: Dec 15, 2022 to Jun 15, 2023
    • Collaborators shortened, about 3 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05585229
Lead Sponsor University of British Columbia
Collaborators: Etheridge Foundation
Conditions
(from sponsor)
Opioid Dependence, Chronic Pain
Related terms Chronic Pain, Opioid-Related Disorders
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov