NCT07406828

Psilocybin After Trauma Surgery for Pain

Single Dose Psilocybin for a Post-surgical Trauma Inpatient Population for Pain, Mood, and Opioid Use Disorder

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Trent Emerick · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an open-label pilot feasibility trial conducted at a single academic medical center. Fourteen participants receive a single oral dose of psilocybin during inpatient hospitalization following trauma surgery. Outcomes in the psilocybin group are compared with a retrospectively identified standard-of-care cohort of 56 trauma surgery patients with opioid use disorder, identified through electronic medical record review. The standard-of-care cohort is selected using propensity score methods based on baseline characteristics, including age, sex, trauma diagnosis, psychiatric comorbidities, baseline medications, comorbid conditions, type of surgery, and baseline opioid consumption measured in morphine milligram equivalents. No interim efficacy analyses are planned. After the first three participants have received psilocybin and completed the one-week follow-up assessments, the Data and Safety Monitoring Board reviews safety data to assess ongoing risk and determine whether study procedures should continue unchanged.

Conditions

• Pain Management
• Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study