Actively Recruiting
Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer
Led by Gustavo Vazquez · Updated on 2026-03-18
15
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.
CONDITIONS
Official Title
Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with advanced stage cancer (stages 3 and 4)
- Aged between 18 and 70 years
- Moderate-to-severe demoralization as measured by Demoralization Scale 60; 30
- English proficiency
- Ability to understand and willingness to sign written informed consent
- Individuals of child-bearing potential who are sexually active must agree to use acceptable contraception during the study and men must use contraception for 4 months after psilocybin administration
You will not qualify if you...
- Condition impairing oral intake or digestive absorption
- Primary brain tumor
- Presence of delirium
- Significant suicide risk with intent and plan
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder
- First-degree relatives with schizophrenia or bipolar disorder
- Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, or Parkinson's disease
- History of allergic reactions to compounds similar to psilocybin
- Personal circumstances or behavior limiting compliance or safe exposure to psilocybin
- Use of medications with significant drug interactions that cannot be tapered, including MAO inhibitors, regular antipsychotics within 6 weeks, mood stabilizers, aldehyde dehydrogenase inhibitors, and significant UGT 1A0 or UGT 1A10 inhibitors
- Elevated liver enzymes 5 times above normal or symptoms of liver failure
- Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, or unstable conditions that may interfere with study or pose health risks
- Pregnant, nursing, or planning pregnancy
- Use of classic psychedelics or MDMA in the past 12 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Actively Recruiting
Research Team
G
Gustavo Vazquez, MD, PhD, FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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