Psilocybin After Trauma Surgery for Pain

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Trent Emerick
Study ID
NCT07406828
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pain Management
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (Usona Institute) — DRUG
    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.
  • Postoperative analgesia — DRUG
    Standard postoperative pain management, including multimodal analgesia and medications for opioid use disorder, provided per institutional clinical practice.

Study Details

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

Key Dates

Start date
Jul 31, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Postoperative Standard of Care
    Participants receive standard postoperative pain management following trauma surgery, including multimodal analgesia and medications for opioid use disorder, as determined by the clinical care team. No psilocybin is administered.
  • Experimental: Single Dose Psilocybin
    Participants receive a single oral dose of psilocybin (10 mg) administered during inpatient hospitalization within 72 hours after trauma surgery, along with the standard postoperative care.

Primary Outcome Measure

Feasibility: Recruitment [ Time Frame: From enrollment and receipt of psilocybin to 3 days post-treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC PresbyterianPittsburghPennsylvania15213
Trent Emerick, MD
[email protected]
412-692-2234
Amy Monroe, MPH, MBA
[email protected]

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By research site
UPMC Presbyterian· Pittsburgh, PA

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