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Psychedelic
Psilocybin for Psychological Distress in Pancreatic and Biliary Tract Cancer
Phase 1
Recruiting
Led By Lou Lukas, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant (male and female) of childbearing potential (defined as age <55 and menses within the prior 2 years with intact ovaries and uterus) must agree to use an adequate method of contraception or birth control from the time of enrollment to 24 hours following the psilocybin session
Participant must have an ECOG performance status of 0-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial tests if psilocybin can help treat distress related to pancreatobilliary cancer. It'll measure if this helps before/after, and if it affects family members, too.
Who is the study for?
This trial is for adults aged 19-85 with inoperable pancreatic or biliary tract cancer experiencing distress. They must speak English, have a life expectancy of at least 8 weeks, and be able to consent to the study. A family member must also participate. Exclusions include severe depression/anxiety, substance abuse, certain medical conditions like CNS metastases or major organ dysfunction, and those on specific medications.Check my eligibility
What is being tested?
The trial tests psilocybin's effect on psychological distress in patients with inoperable pancreatobiliary cancer. It aims to recruit participants and their family members (observational arm) to measure changes in distress levels before and after treatment over time.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of psilocybin may include altered sensory experiences, mood changes, nausea, headache, increased heart rate and blood pressure which can vary based on individual health status.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am under 55, had a menstrual cycle in the last 2 years, and agree to use birth control during the study.
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I can care for myself but may not be able to do heavy physical work.
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My cancer in the pancreas or bile ducts cannot be removed by surgery.
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I am between 19 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment Rate
Retention Rate
Secondary outcome measures
Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose
Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose
Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psilocybin Treatment ArmExperimental Treatment1 Intervention
Participant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session.
Group II: Family Observation GroupActive Control1 Intervention
The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,710 Total Patients Enrolled
Nebraska University FoundationUNKNOWN
Lou LukasLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a problem with alcohol or using drugs for fun, except for caffeine and nicotine.I have heart or blood circulation problems.I am not pregnant or breastfeeding.I am under 55, had a menstrual cycle in the last 2 years, and agree to use birth control during the study.You have tried to harm yourself in the past two years or are at high risk of doing so, according to the Columbia Suicide Severity scale.I have a close family member with schizophrenia, psychotic disorder, or bipolar disorder.I can care for myself but may not be able to do heavy physical work.I am not currently taking any strong drugs that affect how my body processes medications.My cancer in the pancreas or bile ducts cannot be removed by surgery.I understand my cancer is serious and likely cannot be cured.My kidney function is low, with a creatinine clearance under 40 ml/min.I have brain metastases or a major brain condition like Parkinson's.You have a condition that may make it difficult for you to build a good relationship with the study team or have a safe experience with psilocybin, such as dissociative disorder, anorexia nervosa, or bulimia nervosa.You are currently getting treated as part of another research study for cancer.My liver is not functioning properly.I am between 19 and 85 years old.I need immediate treatment for severe depression or anxiety and cannot safely stop my medication for a psilocybin session.I can't skip meals or need diabetes medication more than twice daily, or I've had low blood sugar symptoms recently.I have a history of seizures.I have pancreatic or biliary tract cancer and feel some distress.You have been diagnosed with schizophrenia, psychotic disorder, or bipolar I or II disorder, unless it was caused by substance use or a medical condition.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin Treatment Arm
- Group 2: Family Observation Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Psilocybin Treatment Arm procured FDA authorization?
"With only preliminary data to support its efficacy and safety, Psilocybin Treatment Arm was scored a 1 on our team's scale."
Answered by AI
Is enrollment underway for this research trial currently?
"Reportedly, this medical trial is currently seeking out individuals for enrolment. The initial posting was on April 7th of 2023 and the most recent update to its information occurred on the 14th of that same month."
Answered by AI
What is the current enrollment rate for this clinical trial?
"Indeed, according to the clinicaltrials.gov website this medical research began recruitment on April 7th 2023 and was most recently amended on April 14th of the same year. The trial is currently looking for 24 participants at a single site."
Answered by AI
Does this research study accept volunteers over the age of forty?
"The minimum age for participants in this trial is 19, while the maximum age is 85. Additionally, there are 23 trials specifically targeting patients under 18 and 854 studies dedicated to those 65 years or older."
Answered by AI
Who is eligible to take part in this clinical research study?
"This medical experiment is seeking to recruit 24 individuals, aged 19-85 and suffering from psychological distress. Those hoping to participate must meet the following criteria: do they have a non-zero score on the NCCN Distress Thermometer?, Are they between 19 and 85 years old? Do they possess an unresectable pancreatic or biliary tract cancer (gallbladder adenocarcinoma, cholangiocarcinoma, ampullary adenocarcinoma carcinoma)? Can they communicate in English? What's their ECOG performance status rating 0-3? Is life expectancy of no less"
Answered by AI
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