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Study identifier: NCT06818994 Synced from ClinicalTrials.gov · July 29, 2026
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Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer

Condition: Demoralization · Safety  ·  Sponsor: Gustavo Vazquez

PhasePhase 1
Planned participants15
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of inter…

This description comes directly from the study's public registry record.

Talk to the study team

Gustavo Vazquez, MD, PhD, FRCPC  ·  613-544-4900 x51214  ·  vazquezg@providencecare.ca

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Locations (1)

Queen's UniversityKingston, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06818994