Psilocybin Therapy in Advanced Cancer

NCT05398484 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 22-00498
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 8

Secondary Outcomes (32)

• Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score

  Baseline, Week 8

• Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score

  Baseline, Week 12

• Change in Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (MADRS): SIGMA Score

  Baseline, Month 6

• Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score

  Baseline, Week 8

• Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score

  Baseline, Week 12

Study Arms (2)

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).

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.

Drug: Niacin 100mg; Behavioral: Psychotherapy

Interventions

Psilocybin 25 mgs DRUG

One capsule containing 25mg of psilocybin will be administered with water orally. The appearance of psilocybin is Size 2 HPMC opaque.

Participants receiving Study Drug

Niacin 100mg DRUG

One capsule contains 100mg of niacin will be administered with water orally. The appearance of the active placebo is Size 2 HPMC opaque.

Participants receiving Placebo

Psychotherapy BEHAVIORAL

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.

Participants receiving Placebo; Participants receiving Study Drug

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Colorado Anschutz Medical campus (CU AMC)

Aurora, Colorado, 80045, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39260823 DERIVED

MeSH Terms

Interventions

Niacin; Psychotherapy

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Behavioral Disciplines and Activities

Study Officials

• Stephen Ross, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Weiner, MA

CONTACT

212-263-6283; sydney.weiner@nyulangone.org

Stephen Ross, MD

CONTACT

212-263-6289; stephen.ross@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: May 24, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Stephen.ross@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)