Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers

NCT05220046 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 0860-21-FB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.

Conditions

Pancreas Cancer; Biliary Tract Cancer; Psychological Distress; Gastrointestinal Cancer

Keywords

inoperable; unresectable; stage IV

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  Number of participants enrolled/ number approached.

  18 months

• Retention Rate

  Number of participants who complete the psilocybin session and the assessments at 8-12 days post-psilocybin session/ total enrolled

  24 months

Secondary Outcomes (3)

• Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose

  Baseline; Day 8-11 post-dose

• Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose

  Baseline; Day 8-11 post-dose

• Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose

  Baseline; Day 8-11 post-dose

Study Arms (2)

Psilocybin Treatment Arm

EXPERIMENTAL

Participant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session.

Drug: Psilocybin

Family Observation Group

NO INTERVENTION

The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer.

Interventions

Psilocybin DRUG

Psilocybin, 25mg administered orally drug during an 8-hour monitored session with supportive pre- and post- session counseling

Also known as: mushroom

Psilocybin Treatment Arm

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 19 and 85
• Has stage IV or unresectable GI malignancy
• Resides within a 170-mile radius of Omaha, NE
• Speaks English
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• Life expectancy ≥ 8 weeks as determined by referring oncologist
• Ability to provide written informed consent and comply with study procedures
• Awareness of the neoplastic and likely incurable nature of his/her disease
• Has one family member willing to participate in measures
• Agreeable to using an adequate method of contraception or birth control from the time of enrollment to 24 hours following the psilocybin session (male and female participant of childbearing potential, defined as age \<55 and menses within the prior 2 years with intact ovaries and uterus)
• Negative pregnancy test result (female participants)

You may not qualify if:

• Long-term or unstable psychiatric illness that would prevent safe cessation of psychotropic drugs including MAOIs, lithium, or anti-psychotics
• Severe symptoms of depression or anxiety warranting immediate impatient evaluation or treatment
• High-risk of suicide, as measured by Columbia Suicide Severity rating Scale
• Current or prior history of schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder
• First-degree family member with schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder
• Conditions known to be incompatible with establishment of rapport or safe exposure to psilocybin including dissociative disorder, borderline personality, traumatic brain injury, obsessive compulsive disorder, anorexia nervosa, or bulimia nervosa
• Alcohol or recreational drug abuse disorder, excluding caffeine and nicotine
• Known CNS metastases or other major CNS disease such as seizure disorder, dementia, Parkinson's disease, multiple sclerosis
• Receive treatment in another clinical trial involving an investigational product for the treatment of cancer during the interventional stage of the protocol
• Advanced hepatic dysfunction as indicated by a Child-Pugh Score of C
• Renal dysfunction as indicated by creatinine clearance \<40 ml/min using the Cockroft-Gault equation
• Cardiac or circulatory dysfunction defined as uncontrolled hypertension (systolic blood pressure \> 140 or diastolic blood pressure \>90 mmHg on three separate readings), angina, stroke or myocardial infarction in the prior 6 months, or claudication
• History of seizures
• Unable to skip a meal (lunch), or have diabetes which requires administration of medication more than twice daily, or with symptomatic hypoglycemia within the prior 30 days
• Pregnant or breastfeeding

Sponsors & Collaborators

• University of Nebraska: lead
• Nebraska University Foundation: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Gastrointestinal Neoplasms

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Lou Lukas, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are enrolled as patient/family dyad, with patient in intervention arm and family in observational arm

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: February 2, 2022
• Study Start: April 10, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)