Palliadelic Treatment to Reduce Psychological... — Clinical Trial Details

Non-randomised parallel-design pilot evaluating feasibility, safety and preliminary distress outcomes of a single 25 mg oral psilocybin session in persons with stage IV or unresectable gastrointestinal cancers; each patient recruits a paired family member for observational outcomes.

Preparatory sessions (2–4; delivered outpatient or by telehealth) precede one 8-hour monitored psilocybin dosing session; integration sessions (2–3) follow, delivered in clinic or by phone/telehealth.

Primary and secondary outcomes assessed one week post-treatment with exploratory longitudinal measures up to 12 months including patient distress, family member distress and bereavement, healthcare utilisation and choices regarding anti-cancer treatment.

Participants

Ages

19 – 85

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion 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

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 inpatient 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

Company

Product

Legal

Palliadelic Treatment to Reduce Psychological Distress in Persons With Inoperable Pancreatobiliary Cancer

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin Treatment

Interventions

Family Observation

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators