Who is sponsoring NCT07406828?

NCT07406828 is sponsored by Trent Emerick.

What condition does NCT07406828 study?

NCT07406828 studies Pain Management, Postoperative Pain.

What drugs are being tested in NCT07406828?

Interventions: Psilocybin (Usona Institute), Postoperative analgesia.

What is the status of NCT07406828?

NCT07406828 is currently NOT_YET_RECRUITING.

Last reviewed 2026-02-05 · How we verify

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

NCT07406828 Phase 1 NOT_YET_RECRUITING

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

Details

Lead sponsor	Trent Emerick
Phase	Phase 1
Status	NOT_YET_RECRUITING
Enrolment	70
Start date	2026-07
Completion	2027-08

Conditions

Pain Management
Postoperative Pain

Interventions

Psilocybin (Usona Institute)
Postoperative analgesia

Primary outcomes

Feasibility: Recruitment — From enrollment and receipt of psilocybin to 3 days post-treatment.
Recruitment feasibility will be assessed by calculating the enrollment rate, defined as the number of participants enrolled and receiving psilocybin divided by the number of individuals determined eligible. Accrual rate will be calculated as total enrolled participants divided by the number of months recruitment occurred.
Feasibility: Retention — Day 5 post-treatment
Retention will be calculated as the proportion of enrolled participants who receive treatment and complete required study assessments through follow-up day 5, divided by the number of individuals enrolled, treated, and not withdrawn. Feasibility target: ≥90% retention by day 5.
Feasibility: Completion of One-Month PROs — at 1-month post-treatment
Feasibility will also be assessed by determining the completion rate of patient-reported outcome assessments 1 month after treatment, defined as the number of participants completing PROs divided by the number of enrolled participants who have not withdrawn. Feasibility target: ≥80% PRO completion at 1-month follow-up.

Countries

United States