Palliadelic Treatment To Reduce Psychological Distress In Persons With Advanced Gastrointestinal Cancers

Study Overview

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

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.

Participants with stage IV or inoperable gastrointestinal cancers are eligible for intervention, paired family member recruited for observational arm. Following preparatory sessions in outpatient palliative care clinic or by telehealth (2-4 sessions lasting 60-90 minutes each), psilocybin will be administered as a 25mg capsule during an 8-hour monitored session. Integration sessions (2-3 sessions lasting up to 90 minutes each) will take place in the outpatient palliative care clinic or by phone or tele-heath. Primary and secondary objectives are complete at one-week post treatment, longitudinal exploratory measures collected up to 12 months post baseline. Parallel assessment of health care utilization, including choices regarding anti-cancer treatment and resource utilization, and family member distress, family communication, well-being and bereavement will be conducted at concurrent time points.

Pancreas Cancer
Biliary Tract Cancer
Psychological Distress
Gastrointestinal Cancer

DRUG: Psilocybin

0860-21-FB

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-01-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-06
First Submitted that Met QC Criteria 2022-01-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-11
First Posted (ACTUAL) 2022-02-02	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Psilocybin Treatment Arm Participant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session.	DRUG: Psilocybin Psilocybin, 25mg administered orally drug during an 8-hour monitored session with supportive pre- and post- session counseling
NO_INTERVENTION: Family Observation Group The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Psilocybin Treatment Arm

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

DRUG: Psilocybin

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

NO_INTERVENTION: Family Observation Group

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose	Patient Health Questionnaire-9 (PHQ-9) is a nine-item, 32 point scale of frequency of common depressive symptoms. Higher score indicates worse depression.	Baseline; Day 8-11 post-dose
Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose	Change in General Anxiety DIsorder-7 (GAD-7) is a 7 item, 21 scale to measure frequency of common symptoms of anxiety with higher score indicating higher severity.	Baseline; Day 8-11 post-dose
Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose	Change in Demoralization Scale (D-II) is a 16 item, 32 point scale with two factors, meaning & purpose and distress & coping, that measures frequency of symptoms of demoralization and existential distress, with higher score indicating higher severity.	Baseline; Day 8-11 post-dose

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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)

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
Currently using any of the following potent metabolic inducers or inhibitors

Inducers: rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, St. Johns Wort, or Paclitaxel and dexamethasone (latter two permitted if 5 half-lives have passed between last dose and psilocybin session)
Inhibitors: All HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin
Metal in body (i.e. hearing aid, cardiac pacemaker, bone plates, braces, non-removeable piercings/implants, etc.) claustrophobia, inability to lay still for one-hour, or any other condition that would preclude MRI scanning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Nebraska University Foundation

Investigators

PRINCIPAL_INVESTIGATOR: Lou Lukas, MD, University of Nebraska

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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