Your session is about to expire
← Back to Search
Psychedelic
Psilocybin Therapy for Advanced Cancer
Phase 2 & 3
Recruiting
Led By Stephen Ross, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥ 21
Diagnosis of Advanced (i.e. stage 3 or 4 solid tumors) Cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8, month 6
Awards & highlights
Study Summary
This trial will study the safety and effects of psilocybin in treating anxiety, depression, and existential distress in advanced cancer patients.
Who is the study for?
Adults aged 21+ with advanced stage 3 or 4 cancer experiencing significant depression, anxiety, or existential distress. They must have a support person and agree to use birth control if of childbearing potential. Excluded are those with certain psychiatric disorders, severe heart conditions, epilepsy, dementia, high suicide risk, drug abuse history within the past year, and those on conflicting medications.Check my eligibility
What is being tested?
The trial is testing the effects of a single dose of psilocybin (25mg) versus an active placebo (niacin 100mg) in reducing anxiety and depression associated with advanced cancer. This is paired with brief psychotherapy aimed at addressing emotional distress related to their condition.See study design
What are the potential side effects?
Possible side effects include temporary changes in perception and mood swings during treatment. Niacin may cause flushing or mild dizziness. Long-term psychological effects are unknown but could potentially include persistent altered states of perception.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
My cancer is at an advanced stage (3 or 4).
Select...
I can care for myself and do up to some work despite my illness.
Select...
I am 21 years old or older.
Select...
My cancer is advanced or has come back.
Select...
I have an advanced blood cancer such as late-stage lymphoma, myeloma, or leukemia.
Select...
I can care for myself and do light activities.
Select...
I have someone to take me home after my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8, month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8, month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score
Secondary outcome measures
Change in Clinical Global Impression - Improvement (CGI-I) Score
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Change in Death Transcendence Scale (DTS) Score
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving Study DrugExperimental Treatment2 Interventions
Advanced cancer participants will receive experimental medication, psilocybin (25mg). In addition to the pharmacologic intervention, participants will receive a manualized psychotherapy platform. The combination of interventions is referred to as psilocybin-assisted psychotherapy (PAP).
Group II: Participants receiving PlaceboActive Control2 Interventions
Advanced cancer participants will receive active placebo - single dose of niacin (100mg). In addition to the placebo, participants will receive the same manualized psychotherapy platform as the experimental arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychotherapy
2020
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,426 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,554 Total Patients Enrolled
Stephen Ross, MDPrincipal InvestigatorNYU Langone Medical Center
5 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have respiratory failure.I have a serious brain or spinal cord condition.I have a brain tumor.You have a high risk of suicide or have shown signs of extreme sadness or thoughts of hurting yourself.You have thoughts of hurting yourself or ending your life that the study doctor or principal investigator believes could lead to serious harm.I agree to stop taking niacin 5 days before and during the study.I have been on a stable dose of opiate pain medication for at least 1 month.I agree to use effective birth control during the study.You have been diagnosed with a substance use disorder (SUD) for alcohol or drugs (excluding caffeine and nicotine) in the past year.I am experiencing significant depression or anxiety, or I feel a deep sense of hopelessness.I have been on a stable dose of benzodiazepine or sleeping medication for at least 6 weeks.I agree to stop taking prescribed stimulants like amphetamines and Ritalin 2 weeks before the study starts.I am currently experiencing sudden kidney failure.You have tried to harm yourself in the past year.I have someone to take me home after my treatment.I am not taking any strong inhibitors of UGT 1A0 or UGT 1A10.I have been diagnosed with Bipolar I disorder and experience psychosis.You have an allergy or cannot tolerate any of the ingredients in the drug.I have been diagnosed with major depression that includes psychosis.I am taking antipsychotic medication.I have a condition that affects my heart's rhythm.I have severe liver problems.You have a history of violent behavior.You have used the substance more than 25 times in your lifetime.I am currently taking other medications.I am currently taking medication for mood stabilization.I am not taking any aldehyde dehydrogenase inhibitors.I do not have serious heart rhythm problems or abnormal ECG results.I have a cerebral aneurysm.My cancer is advanced or has come back.I have an advanced blood cancer such as late-stage lymphoma, myeloma, or leukemia.I can care for myself and do light activities.I have had a stroke in the past.You have a condition called schizoaffective disorder.You have a type of mental illness called schizophrenia or related disorders.I am currently taking antidepressants.You have been diagnosed with schizophrenia or a related disorder.I can care for myself and do up to some work despite my illness.My cancer is at an advanced stage (3 or 4).You have schizoaffective disorder.I have been diagnosed with Bipolar I disorder with psychotic features.I have congestive heart failure.I have epilepsy.You have a condition called dementia.I have not experienced episodes of severe confusion (delirium).You have a history of a condition called hallucinogen persisting perception disorder (HPPD).I am not taking any medications that significantly affect serotonin levels in my brain.A close family member has had a serious mental health condition.I experience frequent agitation.You have recently shown signs of wanting to harm yourself or have taken steps towards hurting yourself.I am 21 years old or older.I have recently had a heart attack or signs of poor blood flow to my heart.I have been diagnosed with severe, uncontrolled high blood pressure.My cancer is in an advanced stage.You have severe mental health conditions like schizophrenia or bipolar disorder.I am 21 years old or older.The doctor thinks you might have strong emotional or behavioral reactions that could be harmful. For example:
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving Study Drug
- Group 2: Participants receiving Placebo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cancer Patient Testimony for trial: Trial Name: NCT05398484 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project allow for participants who are 18 or older?
"This study is looking for participants that fall between the ages of 21 to 100. In contrast, there are 319 trials targeting individuals under 18 and 2348 for those over 65."
Answered by AI
What outcomes are researchers hoping to see from this trial?
"The primary outcome of this trial will be evaluated at Week 0 and Week 8, and will focus on change in GRID-Hamilton Depression Rating Scale (GRID-HAMD-17) score. Additionally, secondary outcomes including change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale score, Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale score, and Change in Functional Assessment of Cancer Therapy-General (FACT-G) score will also be monitored."
Answered by AI
Who meets the requirements to take part in this experiment?
"Eligibility requirements for this study are having cancer and being between 21 and 100 years old. So far, around 300 people have been accepted into the trial."
Answered by AI
How can people sign up for this opportunity?
"Unfortunately, the information provided on clinicaltrials.gov suggests that this study is not currently looking for new participants. This trial was first posted on November 1st, 2022 and was last updated on September 14th, 2022. Although this study is not enrolling candidates at this time, there are 2540 other trials presently searching for participants."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
New Jersey
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Colorado Anschutz Medical campus (CU AMC)
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am terminal . I am very depressed, angry and cannot come to terms with my diagnosis.
PatientReceived no prior treatments
I was diagnosed with stage 4 sclc in 2014. I have been diagnosed with severe depression.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- University of Colorado Anschutz Medical campus (CU AMC): < 24 hours
- NYU Langone Health: < 48 hours
Average response time
- < 2 Days
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger