Psilocybin Therapy for Anxiety and Depression in Advanced Cancer
This study is looking at how a single dose of psilocybin (25mg) compares to niacin (100mg), an active placebo, for treating anxiety, depression, and existential distress (feelings of loss of meaning, hope, or fear of death) in people with advanced cancer. Both psilocybin and niacin are given along with psychotherapy sessions. You might be able to join if you are 21 to 100 years old and have advanced cancer (Stage 3 or 4 solid tumors, metastatic illness, recurrent illness, or certain advanced blood cancers). The researchers will measure changes in anxiety levels using a specific scale (SIGH-A) at the beginning of the study and again at Week 8 to see if the treatment is successful. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 200 participants. It compares psilocybin to an active placebo (niacin) in a double-blind, parallel-design, placebo-controlled randomized controlled trial.
- What's involved
- You would receive 6 hours of preparatory psychotherapy before a single medication session, and 8 hours of integration psychotherapy after the dosing session. Anxiety levels will be measured at baseline and Week 8.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up to Week 8, as anxiety levels are measured at baseline and Week 8.
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NCT05398484
Psilocybin Therapy in Advanced Cancer
Recruiting
PHASE2Ages 21+InterventionalTreatmentNYU Langone HealthInvestigator-initiated
~200 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Psilocybin 25 mgsNiacin 100mgPsychotherapy
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score
Measured over Baseline, Week 8
Conditions
Where it's being run
2 sites across 2 statesColorado1
New York1
Study leadership
- Stephen Ross, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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)
What this trial measures
- Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A ScoreBaseline, Week 8
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) measures the level of anxiety in participants. Scoring is based on a 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild anxiety, 17-23 moderate anxiety, and scores over 24 are indicative of severe anxiety; the maximum score being 52.