Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been assessed and found to have an adjustment disorder (a stress-related condition) based on specific questionnaire scores, including a distress score of 4 or higher on a standard scale.
• People whose anxiety has been measured as moderate or higher on a standard anxiety rating scale.
• Adults aged 18 to 80 years old at the time of screening.
• People who have been diagnosed with cancer (excluding certain cancer types listed in the exclusion section below), whose doctor considers them to have a life expectancy of at least 6 months, and who are reasonably functional in daily life based on a standard performance scale.
• People who agree not to start any new psychiatric medications or talking therapies between the screening visit and Week 10 of the study.
• People who are able to communicate well in English, follow study instructions, and build a working relationship with the study team, as judged by the study investigator.
• People who are assessed as being at low risk of suicide, based on a standard tracking scale and review by a study psychiatrist.
• People who are considered medically suitable based on a personal interview, medical questionnaire, physical examination, heart tracing (ECG), and blood tests.
• People who have access to a smartphone or tablet compatible with the study's digital technology.
• People who agree to avoid sedating medications — including certain sleeping tablets and anxiety medications — for at least 12 hours before the dosing session (medications for cancer-related pain are still permitted).
• People who are willing and able to refrain from smoking for the full duration of the dosing session (nicotine replacement may be permitted with agreement from the medical monitor).
• People who agree to avoid recreational drugs, non-prescription medications, cannabis or CBD/THC products, and herbal or nutritional supplements for at least one week before the dosing session, unless approved by investigators; and who agree not to take any form of psilocybin outside of the study from the start of the trial through to Week 10.
• People taking other medications not specifically listed as excluded will be reviewed individually by the investigator and medical monitor, with decisions made based on clinical judgement (confirm with trial site).

Who may not be able to join:

• People with a current or recent (within the past 12 months) diagnosis of major depression considered unrelated to their cancer diagnosis, or a current or past diagnosis of schizophrenia, psychotic disorder (unless caused by a medical condition such as lupus or malaria), bipolar disorder (type I or II), delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or antisocial personality disorder — or anyone assessed as unsuitable for safe participation by a psychiatrist or qualified medical professional.
• People who have a parent, sibling, or child who has been diagnosed with a psychotic disorder.
• People whose suicide risk is assessed as clinically significant based on the standard tracking scale and other clinical information reviewed at screening.
• People who have attempted suicide in the 12 months before the screening visit.
• People with a current (within the past year) moderate or severe alcohol or drug misuse problem as identified during screening, or who are unwilling or unable to avoid alcohol for at least 12 hours before the dosing session.
• People for whom there is any other reason they may not be able to fully take part in the therapeutic preparation and follow-up sessions.
• People who have taken a small (micro) dose of psilocybin within 5 days of the baseline visit, taken a larger dose of psilocybin within 30 days of baseline where it caused euphoria, hallucinations, or altered mental state, or used other classic psychedelic substances (such as LSD, ibogaine, ayahuasca, DMT, or mescaline) within 3 months before the baseline visit.
• People diagnosed with brain metastases (cancer that has spread to the brain), a brain tumour called glioblastoma, a tumour affecting adrenaline levels (phaeochromocytoma), bowel obstruction, active carcinoid syndrome, uncontrolled high calcium levels, or uncontrolled diabetes.
• People currently taking or planning to take antipsychotic medications or monoamine oxidase inhibitor (MAOI) medications — those who have previously used these must be willing to stop for at least 2 weeks before the baseline visit and through to Day 28.
• People currently taking or planning to take anti-seizure medications or mood stabilisers, including carbamazepine, lithium, phenytoin, or valproate — those who have previously used these must be willing to stop for at least 1 week before the baseline visit and through to Day 28.
• People with any form of fungal allergy.
• People who are pregnant, breastfeeding, or capable of becoming pregnant but unwilling or unable to use effective contraception (or abstinence) throughout the study and for 1 month after the psilocybin dose; and male participants who are unwilling to use contraception throughout the study and for 90 days after the psilocybin dose.
• People with a diagnosis of epilepsy or who are considered to be at significant risk of seizures based on their medical history.
• People with certain heart or cardiovascular conditions, including stroke or heart attack within the past year, uncontrolled high blood pressure, or a significant abnormal heart rhythm — though exceptions may apply if these are directly related to the cancer diagnosis and the investigator considers participation safe.
• People whose physical examination, vital signs, heart tracing (ECG), or breath alcohol test show clinically significant abnormal results at screening (specific thresholds apply — confirm with trial site).
• People with liver function test results more than 1.5 times the upper limit of normal, unless this is directly due to the cancer diagnosis and the investigator considers it safe to proceed.
• People with reduced kidney function below a certain level, unless this is directly due to the cancer diagnosis and the investigator considers it safe to proceed (confirm with trial site).
• People with any other laboratory test abnormality that the investigator considers a risk for receiving psilocybin.
• People with a significant kidney, lung, digestive, liver, or other illness that could affect the study results or pose a health risk — exceptions may apply if these are directly related to the cancer diagnosis.
• People with a Body Mass Index (BMI) below 18 or above 32 at screening (BMI is a measure calculated from height and weight).
• People with a brain injury or any diagnosed cognitive impairment (such as a condition affecting memory or thinking).
• People who test positive for non-prescribed psychoactive substances in a urine drug test at the dosing session visit.
• People who are currently taking part in another clinical trial involving an experimental drug, or who have taken part in a clinical trial within the past 3 months.

Important: Always verify eligibility with the trial site directly before applying.