Pancreas CancerPhase 1NCT05220046
Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers
A Phase 1 study testing Psilocybin in people with Pancreas Cancer and Biliary Tract Cancer, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pancreas Cancer, Biliary Tract Cancer, Psychological Distress
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 17 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress in People With Pancreatobiliary and Other 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.
Read the 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.
- Being tested
- Psilocybin
- Keywords
- inoperable, unresectable, stage IV
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called mushroom
Psilocybin, 25mg administered orally drug during an 8-hour monitored session with supportive pre- and post- session counseling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled/ number approached.
Measured: 18 months
Retention Rate
Number of participants who complete the psilocybin session and the assessments at 8-12 days post-psilocybin session/ total enrolled
Measured: 24 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline; Day 8-11 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start10 Apr 2023
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are enrolled as patient/family dyad, with patient in intervention arm and family in observational arm
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Nebraska University Foundation
- Responsible party
- Sponsor
- Investigators
- Lou Lukas, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220046
- Sponsor's protocol ID
- 0860-21-FB
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress in People With Pancreatobiliary and Other Advanced Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT05220046
- Acronym / sponsor ID
- 0860-21-FB
- Keywords
- inoperable, unresectable, stage IV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Nebraska University Foundation
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are enrolled as patient/family dyad, with patient in intervention arm and family in observational arm
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Treatment Arm | Experimental | Drug: PsilocybinParticipant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session. |
| Family Observation Group | No intervention | –The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: mushroomPsilocybin, 25mg administered orally drug during an 8-hour monitored session with supportive pre- and post- session counseling | Drug | Psilocybin Treatment Arm |
Primary outcome
Recruitment Rate
Time frame: 18 months
Number of participants enrolled/ number approached.
Retention Rate
Time frame: 24 months
Number of participants who complete the psilocybin session and the assessments at 8-12 days post-psilocybin session/ total enrolled
3 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose
Time frame: Baseline; Day 8-11 post-dose
Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose
Time frame: Baseline; Day 8-11 post-dose
Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose
Time frame: Baseline; Day 8-11 post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lou Lukas, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Pancreas Cancer and Biliary Tract Cancer, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.