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 inoperable pancreaticobiliary cancer. Secondary objectives include pre/post and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.
Compound Psilocybin
Country United States of America
Visit trial
Status
Not yet recruiting
Results Published
No
Start date
10 May 2022
End date
10 October 2024
Chance of happening
69%
Phase
Phase I
Design
Open
Type
Interventional
Generation
First
Participants
24
Sex
All
Age
19- 85
Therapy
Yes
Trial Details
Participants with unresectable pancreas or biliary tract cancers are eligible for intervention, paired family members recruited for an observational arm. Following preparatory sessions in an 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 telehealth. 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.NCT Number NCT05220046
Sponsors & Collaborators
University of NebraskaResearch with psychedelics is underway at the University of Nebraska. At the UN Medical Centre, Lou Lukas is using psychedelics to improve the quality of life of people in palliative care.
Measures Used
Patient Health Questionnaire for DepressionThe PHQ-9 is the module of the Patient Health Questionnaire focusing on major depressive disorder (MDD). It is a 3-page questionnaire that can be entirely self-administered by the patient, after which it is checked by a medical professional. The PHQ-9 consists of 9 items. If 5 or more criteria have been met, the patient is diagnosed with depression.