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

NCT05220046 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Psilocybin

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

Sponsors & Collaborators

  • Nebraska University Foundation

    collaborator UNKNOWN

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Lou Lukas, MD · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220046 on ClinicalTrials.gov