Advanced CancerPhase 2/3NCT05398484
Psilocybin Therapy in Advanced Cancer
A Phase 2/3 study testing Psilocybin 25 mgs, Niacin 100mg and Psychotherapy in people with Advanced Cancer, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Psilocybin 25 mgs, Niacin 100mg and Psychotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2023to 1 Jan 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical campus (CU AMC)
Aurora, Colorado, 80045
Stacy Fischer, MD, 303-724-2406, Stacy.Fischer@cuanschutz.edu
Mary Mancuso, 303-724-5729, mary.mancuso@cuanschutz.edu
- Recruiting
NYU Langone Health
New York, New York, 10016
Sydney Weiner, MA, 212-263-6283, sydney.weiner@nyulangone.org
Stephen Ross, MD, 212-263-6289, stephen.ross@nyulangone.org
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.
Read the detailed description
This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (anxiety, depression) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage or advanced cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral 'high' dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.
- Conditions
- Advanced Cancer
- Being tested
- Psilocybin 25 mgs, Niacin 100mg, Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 25 mgsDrug
One capsule containing 25mg of psilocybin will be administered with water orally. The appearance of psilocybin is Size 2 HPMC opaque.
Niacin 100mgDrug
One capsule contains 100mg of niacin will be administered with water orally. The appearance of the active placebo is Size 2 HPMC opaque.
PsychotherapyBehavioural
The manualized psychotherapy platform will consist of 6 hours of preparatory psychotherapy (prior to the single medication session) and 8 hours of integration psychotherapy following the dosing session.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Study Drug | Experimental | 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). Receives: Drug: Psilocybin 25 mgs; Behavioral: Psychotherapy |
| Participants receiving Placebo | Active comparator | 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. Receives: Drug: Niacin 100mg; Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score
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.
Measured: Baseline, Week 8
Secondary outcomes (32)
Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score
Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (SIGMA) measures the level of depression in participants. Scoring is based on a 10-item rating scale and each item is rated on a 0 (least severe) to 6 (most severe) scale, resulting in a maximum total score of 60 points.
Measured: Baseline, Week 8
Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score
Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (SIGMA) measures the level of depression in participants. Scoring is based on a 10-item rating scale and each item is rated on a 0 (least severe) to 6 (most severe) scale, resulting in a maximum total score of 60 points.
Measured: Baseline, Week 12
Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score
Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (SIGMA) measures the level of depression in participants. Scoring is based on a 10-item rating scale and each item is rated on a 0 (least severe) to 6 (most severe) scale, resulting in a maximum total score of 60 points.
Measured: Baseline, Month 6
Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
The Hospital Anxiety and Depression Scale (HADS) comprises seven questions about depression. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
Measured: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
The Hospital Anxiety and Depression Scale (HADS) comprises seven questions about depression. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
Measured: Baseline, Week 12
Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
The Hospital Anxiety and Depression Scale (HADS) comprises seven questions about depression. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
Measured: Baseline, Month 6
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
The Hospital Anxiety and Depression Scale (HADS) comprises seven questions about anxiety. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of anxiety.
Measured: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
The Hospital Anxiety and Depression Scale (HADS) comprises seven questions about anxiety. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of anxiety.
Measured: Baseline, Week 12
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
The Hospital Anxiety and Depression Scale (HADS) comprises seven questions about anxiety. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of anxiety.
Measured: Baseline, Month 6
Changes in Demoralization Scale Version II (DS-II) Score
The Demoralization Scale Version II (DS-II) is a validated and frequently used instrument to assess existential distress in patients with cancer and other severe medical illness. Items are rated on a 3-point Likert scale ranging from 0 (never) to 2 (often), with two subscales (Meaning and Purpose; Distress \& Coping Ability). A total score for demoralization is calculated by summarizing the single subscale scores; the total score range is 0-32. Higher scores indicate higher levels of demoralization.
Measured: Baseline, Week 8
Changes in Demoralization Scale Version II (DS-II) Score
The Demoralization Scale Version II (DS-II) is a validated and frequently used instrument to assess existential distress in patients with cancer and other severe medical illness. Items are rated on a 3-point Likert scale ranging from 0 (never) to 2 (often), with two subscales (Meaning and Purpose; Distress \& Coping Ability). A total score for demoralization is calculated by summarizing the single subscale scores; the total score range is 0-32. Higher scores indicate higher levels of demoralization.
Measured: Baseline, Week 12
Changes in Demoralization Scale Version II (DS-II) Score
The Demoralization Scale Version II (DS-II) is a validated and frequently used instrument to assess existential distress in patients with cancer and other severe medical illness. Items are rated on a 3-point Likert scale ranging from 0 (never) to 2 (often), with two subscales (Meaning and Purpose; Distress \& Coping Ability). A total score for demoralization is calculated by summarizing the single subscale scores; the total score range is 0-32. Higher scores indicate higher levels of demoralization.
Measured: Baseline, Month 6
Change in Death and Dying Distress Scale Version 2 (DADDS-2) Score
Death and Dying Distress Scale Version 2 (DADDS-2) scale is a 15-item self-report measure assessing distress regarding awareness of shortness of time and the process of dying, specifically in patients with advanced cancer. The total score range is 0-75. Higher Scores indicate greater death distress.
Measured: Baseline, Week 8
Change in Death and Dying Distress Scale Version 2 (DADDS-2) Score
Death and Dying Distress Scale Version 2 (DADDS-2) scale is a 15-item self-report measure assessing distress regarding awareness of shortness of time and the process of dying, specifically in patients with advanced cancer. The total score range is 0-75. Higher Scores indicate greater death distress.
Measured: Baseline, Week 12
Change in Death and Dying Distress Scale Version 2 (DADDS-2) Score
Death and Dying Distress Scale Version 2 (DADDS-2) scale is a 15-item self-report measure assessing distress regarding awareness of shortness of time and the process of dying, specifically in patients with advanced cancer. The total score range is 0-75. Higher Scores indicate greater death distress.
Measured: Baseline, Month 6
Change in Death Transcendence Scale (DTS) Score
Death Transcendence Scale (DTS) is a 15-item self-report measure assessing distress regarding awareness of shortness of time and the process of dying, specifically in patients with advanced cancer. The total score range is 0-75. Higher Scores indicate greater death distress.
Measured: Baseline, Week 8
Change in Death Transcendence Scale (DTS) Score
Death Transcendence Scale (DTS) is a 15-item self-report measure assessing distress regarding awareness of shortness of time and the process of dying, specifically in patients with advanced cancer. The total score range is 0-75. Higher Scores indicate greater death distress.
Measured: Baseline, Week 12
Change in Death Transcendence Scale (DTS) Score
Death Transcendence Scale (DTS) is a 15-item self-report measure assessing distress regarding awareness of shortness of time and the process of dying, specifically in patients with advanced cancer. The total score range is 0-75. Higher Scores indicate greater death distress.
Measured: Baseline, Month 6
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of Health-related quality of life (HRQOL) in cancer patients: Physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e., at least 22 of the 27 items were answered) and has a possible range of 0-108 points. The lower the score, the greater the quality of life
Measured: Baseline, Week 8
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of Health-related quality of life (HRQOL) in cancer patients: Physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e., at least 22 of the 27 items were answered) and has a possible range of 0-108 points. The lower the score, the greater the quality of life
Measured: Baseline, Week 12
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of Health-related quality of life (HRQOL) in cancer patients: Physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e., at least 22 of the 27 items were answered) and has a possible range of 0-108 points. The lower the score, the greater the quality of life
Measured: Baseline, Month 6
Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score
The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. Answers are scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 48, higher scores indicating higher spiritual well-being.
Measured: Baseline, Week 8
Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score
The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. Answers are scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 48, higher scores indicating higher spiritual well-being.
Measured: Baseline, Week 12
Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score
The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. Answers are scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 48, higher scores indicating higher spiritual well-being.
Measured: Baseline, Month 6
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness (CGI-S) is a standardized assessment scale for determining the effects of mental health treatment among patients with psychiatric illnesses and measures symptom severity, intervention response and the efficacy of interventions in intervention studies of patients with mental disorders. It is a 7-item clinician-administered questionnaire scoring severity of current illness from Normal, not ill at all (1) to Among the most extremely ill patients (7).
Measured: Baseline, Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness (CGI-S) is a standardized assessment scale for determining the effects of mental health treatment among patients with psychiatric illnesses and measures symptom severity, intervention response and the efficacy of interventions in intervention studies of patients with mental disorders. It is a 7-item clinician-administered questionnaire scoring severity of current illness from Normal, not ill at all (1) to Among the most extremely ill patients (7).
Measured: Baseline, Week 12
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness (CGI-S) is a standardized assessment scale for determining the effects of mental health treatment among patients with psychiatric illnesses and measures symptom severity, intervention response and the efficacy of interventions in intervention studies of patients with mental disorders. It is a 7-item clinician-administered questionnaire scoring severity of current illness from Normal, not ill at all (1) to Among the most extremely ill patients (7).
Measured: Baseline, Month 6
Change in Clinical Global Impression - Improvement (CGI-I) Score
Clinical Global Impression - Improvement (CGI-I) is a standardized assessment scale for rating a participant's global improvement relative to treatment intervention. It is a 7-item clinician-administered questionnaire scoring improvement of current illness from Much Improved (1) to Very much Worse (7).
Measured: Baseline, Week 8
Change in Clinical Global Impression - Improvement (CGI-I) Score
Clinical Global Impression - Improvement (CGI-I) is a standardized assessment scale for rating a participant's global improvement relative to treatment intervention. It is a 7-item clinician-administered questionnaire scoring improvement of current illness from Much Improved (1) to Very much Worse (7).
Measured: Baseline, Week 12
Change in Clinical Global Impression - Improvement (CGI-I) Score
Clinical Global Impression - Improvement (CGI-I) is a standardized assessment scale for rating a participant's global improvement relative to treatment intervention. It is a 7-item clinician-administered questionnaire scoring improvement of current illness from Much Improved (1) to Very much Worse (7).
Measured: Baseline, Month 6
Change in Persisting Effects Questionnaire (PEQ) Score
Persisting Effects Questionnaire (PEQ) Score is a self-report measure that was designed to assess positive and negative changes in moods, attitudes, behavior, as well as meaningfulness and spiritual significance attributed to psilocybin administration. The abbreviated questionnaire has 14 items pertaining to the participant's experience as it relates to various aspects of life and whether it has led to long-term and persisting changes.
Measured: Week 8, Month 6
Mystical Experience Questionnaire-30 items (MEQ-30) Score
The Mystical Experience Questionnaire (MEQ) is an unvalidated self-report measure that has been used to measure mystical-type experiences in laboratory studies of hallucinogens. Scoring consists of 0 - none; not at all; 1 - so slight cannot decide; 2 - slight; 3- moderate; 4 - strong (equivalent in degree to any other strong experience); 5- extreme (more than any other time in my life and stronger than 4). MEQ30 total scores range from 0 to 150; the higher the score, the greater the mystical-type experiences occasioned by psilocybin
Measured: 8 hours post-medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start24 May 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Ross, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398484
- Sponsor's protocol ID
- 22-00498
- Status last verified
- Oct 2026
- First submitted
- 26 May 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Schipper S, Nigam K, Schmid Y, Piechotta V, Ljuslin M, Beaussant Y, Schwarzer G, Boehlke C. Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases. Cochrane Database Syst Rev. 2024 Sep 12;9(9):CD015383. doi: 10.1002/14651858.CD015383.pub2.
PubMed 39260823
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer
- ClinicalTrials.gov ID
- NCT05398484
- Acronym / sponsor ID
- 22-00498
- Conditions
- Advanced Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.
Detailed description
This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (anxiety, depression) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage or advanced cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral 'high' dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Study Drug | Experimental | Drug: Psilocybin 25 mgs, Behavioral: PsychotherapyAdvanced 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). |
| Participants receiving Placebo | Active comparator | Drug: Niacin 100mg, Behavioral: PsychotherapyAdvanced 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 21
- Diagnosis of Advanced Cancer defined as:
- 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
Key exclusion criteria (57 listed)
- 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:
- 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 psychotic or affective psychotic disorders. Some examples include current or past DSM-5 criteria for:
- Family history of first-degree relative with psychotic or serious bipolar spectrum illness. Examples include first-degree relative with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin 25 mgsOne capsule containing 25mg of psilocybin will be administered with water orally. The appearance of psilocybin is Size 2 HPMC opaque. | Drug | Participants receiving Study Drug |
| Niacin 100mgOne capsule contains 100mg of niacin will be administered with water orally. The appearance of the active placebo is Size 2 HPMC opaque. | Drug | Participants receiving Placebo |
| PsychotherapyThe manualized psychotherapy platform will consist of 6 hours of preparatory psychotherapy (prior to the single medication session) and 8 hours of integration psychotherapy following the dosing session. | Behavioural | Participants receiving Placebo, Participants receiving Study Drug |
Primary outcome
Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score
Time frame: Baseline, 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.
32 secondary outcomes
Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score
Time frame: Baseline, Week 8
Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score
Time frame: Baseline, Week 12
Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score
Time frame: Baseline, Month 6
Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
Time frame: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
Time frame: Baseline, Week 12
Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
Time frame: Baseline, Month 6
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
Time frame: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
Time frame: Baseline, Week 12
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
Time frame: Baseline, Month 6
Changes in Demoralization Scale Version II (DS-II) Score
Time frame: Baseline, Week 8
Changes in Demoralization Scale Version II (DS-II) Score
Time frame: Baseline, Week 12
Changes in Demoralization Scale Version II (DS-II) Score
Time frame: Baseline, Month 6
Change in Death and Dying Distress Scale Version 2 (DADDS-2) Score
Time frame: Baseline, Week 8
Change in Death and Dying Distress Scale Version 2 (DADDS-2) Score
Time frame: Baseline, Week 12
Change in Death and Dying Distress Scale Version 2 (DADDS-2) Score
Time frame: Baseline, Month 6
Change in Death Transcendence Scale (DTS) Score
Time frame: Baseline, Week 8
Change in Death Transcendence Scale (DTS) Score
Time frame: Baseline, Week 12
Change in Death Transcendence Scale (DTS) Score
Time frame: Baseline, Month 6
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
Time frame: Baseline, Week 8
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
Time frame: Baseline, Week 12
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
Time frame: Baseline, Month 6
Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score
Time frame: Baseline, Week 8
Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score
Time frame: Baseline, Week 12
Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score
Time frame: Baseline, Month 6
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: Baseline, Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: Baseline, Week 12
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: Baseline, Month 6
Change in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Baseline, Week 8
Change in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Baseline, Week 12
Change in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Baseline, Month 6
Change in Persisting Effects Questionnaire (PEQ) Score
Time frame: Week 8, Month 6
Mystical Experience Questionnaire-30 items (MEQ-30) Score
Time frame: 8 hours post-medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Derived from this study: PubMed 39260823Schipper S, Nigam K, Schmid Y, Piechotta V, Ljuslin M, Beaussant Y, Schwarzer G, Boehlke C. Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases. Cochrane Database Syst Rev. 2024 Sep 12;9(9):CD015383. doi: 10.1002/14651858.CD015383.pub2.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Ross, MD principal investigator
NYU Langone Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Psilocybin 25 mgs, Niacin 100mg and Psychotherapy in people with Advanced Cancer, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tallulah Laska (212-263-6283, Tallulah.laska@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.