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

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Description

This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (depression, anxiety) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with 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 dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.

Details
Age

Adult

Eligibility

Diagnosis of advanced cancer Ongoing depression/anxiety/demoralization. General overall ability to function and no major organ failure

Aged 21 or older Diagnosis of Advanced Cancer Functional Status defined as o Eastern Cooperative Oncology Group (ECOG) greater than or equal to 2 o Palliative Performance Scale (PPS) 60% Clinically significant emotional distress defined as either o Hospital Anxiety and Depression (HADS) Total score >12 at Screening o DS Total score >30 and HADS > 8 at Screening Have an identified support person o Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study. A person of childbearing potential is anyone born female 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.

Type of Study

Treatment

Locations

Department Specific Free Standing Clinic
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Stacy Fischer,  MD

Stacy Fischer, MD

Study ID

Protocol Number: 22-1207

More information available at ClinicalTrials.gov: NCT05398484

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