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

Psilocybin

Brief 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 inoperable pancreatobilliary 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.

Intervention / Treatment

  • Drug: Psilocybin

Condition or Disease

  • Pancreas Cancer
  • Biliary Tract Cancer
  • Psychological Distress

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 19 Years to 85 Years   (Adult, Older Adult)
Enrollment: 24 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: May 01, 2022
Primary Completion: Oct 01, 2023
Completion Date: Oct 01, 2024
Study First Posted: Feb 02, 2022
Last Updated: Feb 18, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Participants with unresectable pancreas or biliary tract 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.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT05220046
Other IDs: 860-21
Study URL: https://ClinicalTrials.gov/show/NCT05220046
Last updated: Jun 17, 2022