Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***

Primary Objective

The purpose of this trial is to study the effects of psilocybin-assisted psychotherapy to treat anxiety, depression, and existential distress (demoralization, death anxiety), and quality of life for individuals with late stage or advanced cancer, as compared to an active placebo plus psychotherapy.

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Description

This multi-center trial will enroll 200 participants across two sites. During the randomized, controlled phase of the study, participants will receive either a single 25mg oral ‘high’ dose of psilocybin or an active placebo (100mg niacin), alongside psychotherapy. During the open-label phase, participants will have the opportunity to receive a single 25mg oral ‘high’ dose of psilocybin, alongside psychotherapy..

Main Procedures Involved: A participant will be required to do the following: 1. Attend in-person visits for Screening, Baseline, medication administration, and final follow-up (two additional visits if participating in open-label). Visits will consist of: o Medical history and physical o Electrocardiogram (ECG) o Safety and laboratory assessments (including blood and urine testing) o Psychological assessments 2. Attend study visits, consisting of psychological assessments or preparatory and integration sessions with study therapists (option to be virtual) 3. Must have a support person to accompany them following the dosing session

Duration of Participation: Total study participation will be approximately 43 hours across 7 months; the extended open-label phase is approximately 27 hours across 6 months.

Details
Age

Adult

Eligibility

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

Locations

Department Specific Free Standing Clinic
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of STACY FISCHER

STACY FISCHER

Study ID

Protocol Number: 22-1207

More information available at ClinicalTrials.gov: NCT05398484

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