Psilocybin molecule:

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Psilocybin Clinical Trials

Psilocybin for Psychological and Existential Distress in Palliative Care: A Multi-site, Open-label, Single Arm Phase 1/2 Proof-of-concept, Dose-finding, and Feasibility Clinical Trial

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Id: NCT04754061

Organisation Name: Ottawa Hospital Research Institute

Overal Status: Not yet recruiting

Start Date: March 2022

Last Update: November 18, 2021

Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary: The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered via oral capsules by the participant. Feasibility (recruitment rate, rate of intervention and follow-up completion), safety (rate of adverse events), dosing, and preliminary efficacy (depression, anxiety, overall well-being, and global impression of change) will be measured.

  • Depression, Anxiety
  • Distress, Emotional

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