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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).

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.

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

Psilocybin 25 mgs

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

Niacin 100mg

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.

Psychotherapy

Angela West

Stephen Ross, MD

Stacy Fischer, MD

Mary Mancuso

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.

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.

Psilocybin Therapy in Advanced Cancer

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

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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.

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.

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.

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.

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.

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.

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.

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

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.

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).

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).

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.

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

Spots Global Cancer Trial Database for Psilocybin Therapy in Advanced Cancer

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