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NCT05220046 · ClinicalTrials.gov record · last posted 2026-08-19

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

StatusCompleted
PhasePhase 1
Started2023-04-10
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from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-20
Trial completed
2026-08-20
Enrollment reduced: 24 → 18 participants
2026-08-20
Primary completion moved earlier: 2026-05 → 2025-11-17
2026-08-20
Completion moved earlier: 2026-05 → 2025-11-17
Trial Details
NCT Number NCT05220046
Lead Sponsor University of Nebraska
Collaborators: Nebraska University Foundation
Conditions Pancreas Cancer, Biliary Tract Cancer, Psychological Distress, Gastrointestinal Cancer
Enrollment 18 participants
Start Date 2023-04-10
Primary Completion 2025-11-17 (estimated)
Study Completion 2025-11-17 (estimated)
Updated on ClinicalTrials.gov 2026-08-19