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Psilocybin After Trauma Surgery for Pain

NCT07406828 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-06

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether a single dose of psilocybin is feasible and safe for adults with opioid use disorder (OUD) who are recovering from trauma surgery. The main questions it aims to answer are:

1. Is a single psilocybin dose feasible to administer during postoperative hospitalization?
2. Is psilocybin safe in this patient population?
3. How does psilocybin affect postoperative pain, opioid use, anxiety, and depression after hospital discharge?

Participants will:

Receive one oral dose of psilocybin during their postoperative inpatient stay Complete assessments of pain, mood, and opioid use during recovery

Conditions

  • Pain Management
  • Postoperative Pain

Interventions

DRUG

Psilocybin (Usona Institute)

Single oral dose of psilocybin (10 mg) administered once during inpatient hospitalization to postoperative trauma surgery patients with opioid use disorder, followed by an 8-hour monitored observation period.

DRUG

Postoperative analgesia

Standard postoperative pain management, including multimodal analgesia and medications for opioid use disorder, provided per institutional clinical practice.

Sponsors & Collaborators

  • The Beckwith Institute

    collaborator OTHER

  • Trent Emerick

    lead OTHER

Principal Investigators

  • Trent D. Emerick · University of Pittsburgh / UPMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-12-31
Primary Completion
2029-04-30
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07406828 on ClinicalTrials.gov