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


To see complete record on clinicaltrials.gov, please visit this link

Id: NCT04754061

Organisation Name: Ottawa Hospital Research Institute

Overal Status: Not yet recruiting

Start Date: August 2021

Last Update: April 1, 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.

Conditions:
  • Depression, Anxiety
  • Distress, Emotional


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