NCT05220046

Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers

An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress in People With Pancreatobiliary and Other Advanced Gastrointestinal Cancers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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 stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.

Detailed description

Participants with stage IV or inoperable gastrointestinal 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.

Conditions

• Pancreas Cancer
• Biliary Tract Cancer
• Psychological Distress
• Gastrointestinal Cancer

Interventions

Type	Name	Description
DRUG	Psilocybin	Psilocybin, 25mg administered orally drug during an 8-hour monitored session with supportive pre- and post- session counseling

Timeline

• Start date: 2023-04-10
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-02-02
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study