Magic mushroom compound may ease despair in advanced cancer patients
NCT ID NCT06818994
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests whether psilocybin (the active ingredient in magic mushrooms) combined with talk therapy can safely reduce demoralization in people with advanced cancer. Fifteen participants aged 18-70 will receive one 25 mg dose of psilocybin during an 8-hour supervised session, plus several therapy sessions before and after. The study measures changes in demoralization, depression, anxiety, and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- psilocybin (a psychedelic compound)
- What this could lead to
- If it works, this could point toward a new treatment for demoralization in advanced cancer patients, improving their mental well-being.
- What could go wrong
- This is a very small, early-phase pilot study with only 15 people, so results may not apply broadly. Psilocybin can cause intense psychological experiences and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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≥ 30 * English proficiency * Ability to understand and the willingness to sign a written informed consent document. * Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration. Exclusion Criteria: * Condition impairing oral intake or digestive absorption. * Primary brain tumor. * Presence of delirium. * Significant suicide risk as defined by suicidal ideation with intent and a plan. * Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history. * Patients with first-degree relatives with schizophrenia or bipolar disorder * Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, and Parkinson's disease. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin. * Other personal circumstances and behavior that would limit compliance with study requirements or that are judged by the study psychiatrist and/or principal investigator to be incompatible with establishing rapport or safe exposure to psilocybin. * Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following: * MAO inhibitors * Patients currently on antipsychotics (e.g. first and second generation) when taken regularly (6 weeks or less prior to screening visit) * Mood stabilizers (e.g. lithium, valproic acid, lamotrigine) * Aldehyde dehydrogenase inhibitors (e.g. disulfiram) * Significant inhibitors of UGT 1A0 or UGT 1A10 * Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork performed at screening and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice. * Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver dysfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass. * Women who are pregnant, nursing, or planning a pregnancy. * Use of a classic psychedelic or MDMA in the last 12 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Queen's University
RECRUITINGKingston, Ontario, K7L 3N6, Canada
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