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Magic mushroom therapy aims to ease cancer Patients' fear of death

NCT ID NCT05398484

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a single dose of psilocybin (the active ingredient in magic mushrooms) combined with talk therapy can reduce anxiety, depression, and existential distress in people with advanced cancer. Two hundred participants will receive either psilocybin or an active placebo (niacin) along with psychotherapy. The goal is to see if this approach improves emotional well-being and quality of life.

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) combined with psychotherapy
What this could lead to
If it works, this could offer a new way to reduce severe anxiety, depression, and fear of death in people with advanced cancer.
What could go wrong
This is an early-to-mid stage trial with only 200 participants. The active placebo (niacin) may not fully blind participants, and psilocybin can cause intense psychological experiences. Results may not apply to all cancer patients.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

21 to 100 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged ≥ 21 * Diagnosis of Advanced Cancer defined as: * Solid tumors to include stage 3 or 4, metastatic illness, or recurrent illness * Hematologic malignancies to include, but not limited to, Stage 3 or 4 non-Hodgkins lymphoma, late-stage multiple myeloma or second-line therapy for multiple myeloma, and all forms of acute myeloid leukemia * Functional Status defined as: Eastern Cooperative Oncology Group (ECOG) ≤2 and Palliative Performance Scale (PPS) ≥60% * Clinically significant Anxiety defined as SIGH-A \>17 at Screening * Have an identified support person: agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing * Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. A person of childbearing potential is anyone assigned female or intersex at birth who has experienced menarche and who has not undergone surgical sterilization (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or has not completed menopause. Menopause is defined clinically as 12 months of amenorrhea in a person over age 45 in the absence of other biological, physiological, or pharmacological causes. Exclusion Criteria: * Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: * Congestive heart failure * Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \> 450) * Recent acute myocardial infarction or evidence of ischemia * Malignant hypertension * Congenital long QT syndrome * Acute renal failure * Severe hepatic impairment * Respiratory failure * Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure \>140/90 mmHg. * Significant central nervous system (CNS) pathology. Some examples include: * Primary or secondary cerebral neoplasm * Epilepsy * History of stroke * Cerebral aneurysm * Dementia * Delirium * Primary psychotic or affective psychotic disorders. Some examples include current or past DSM-5 criteria for: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I with psychotic features * Major Depressive Disorder with psychotic features * Family history of first-degree relative with psychotic or serious bipolar spectrum illness. Examples include first-degree relative with: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I with psychotic features * High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: * Agitation * Violent behavior * Active substance use disorders (SUDs) defined as: DSM-5 criteria for alcohol or drug use disorder (excluding caffeine and nicotine) within the past year * Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: * Any use in the last 12 months * \>25 lifetime uses * Clinically significant suicidality or high risk of completed suicide defined as: * Active suicidal behavior (interrupted or aborted attempt; preparatory acts) as assessed by Baseline Version of C-SSRS. If C-SSRS items are 4 or 5, participant is ineligible * History of suicide attempt(s) within the past year * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior * History of hallucinogen persisting perception disorder (HPPD) * Cognitive impairment as defined by: Montreal Cognitive Assessment Test (MoCA) \< 23 * Concurrent Medications * Antidepressants * Centrally-acting serotonergic agents (e.g., MAO inhibitors) * Antipsychotics (e.g., first and second generation) * Mood stabilizers (e.g., lithium, valproic acid) * Aldehyde dehydrogenase inhibitors (e.g., disulfiram) * Significant inhibitors of UGT 1A0 or UGT 1A10 * Niacin. Note: If taking any supplement containing niacin, agrees to suspend use for at least five days prior to dosing and for the duration of the study * Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC). * Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications. * Note: Prescribed benzodiazepine medications and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications. * Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study. * Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use two weeks prior to baseline visit, as confirmed with a negative Baseline drug test, and through to the end of the study. * Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin * Participants who are pregnant, as indicated by a positive urine pregnancy test at Screening, Baseline, or prior to dosing on medication administration sessions. Participants who intend to become pregnant during the study or who are currently nursing. * Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study. * Have an allergy or intolerance to any of the materials contained in either drug product * Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • University of Colorado Anschutz Medical campus (CU AMC)

    RECRUITING

    Aurora, Colorado, 80045, United States

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Other studies related to the condition(s) this trial covers.