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

NCT ID: NCT05220046

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2026-05-31

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

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

Family Observation Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psilocybin

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

Intervention Type: DRUG

Other Intervention Names

mushroom

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nebraska University Foundation

UNKNOWN

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lou Lukas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0860-21-FB

Identifier Type: -

Identifier Source: org_study_id