drugset / Trial / NCT05220046
Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers
Phase 1
Active not recruiting
24 enrolled
University of Nebraska
Nebraska University Foundation · collab
Non-randomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2023-04-10
- Primary completion
- 2026-05
- Completion
- 2026-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 25 mg | Oral |