Psilocybin After Trauma Surgery for Pain
Starting soon · Phase 1
Conditions studied: Pain Management, Postoperative Pain
In brief
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 facts
- Study ID
- NCT07406828
- Run by
- Trent Emerick
- People needed
- 70
- Starts
- 2027-12-31
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 25 years old and ≤65 years old
- Inpatient
- English-speaking
- History of opioid use disorder as diagnosed by DSM-V
- Able to swallow capsules.
- Patients are able to be enrolled and receive psilocybin within 3 days (72 hours) of surgery (time point 0 for this three-day window begins after patient arrival in the ICU) after a trauma surgery. Psilocybin will be administered in the morning to allow for the 8-hour monitoring period.
You may not qualify if…
- Pregnancy. Women of child-bearing potential need to have a negative pregnancy test result at screening and baseline.
- Sexually active male participants and/or their female partners and female participants of child-bearing potential need to be on adequate and effective method of contraception (diaphragm, male condom, combined pill, copper IUD, levonorgestrel IUS, etonogestrel implant).for one week following study drug administration.
- Breastfeeding
- Patients receiving concurrent ketamine therapy or who have received ketamine therapy during the trauma admission.
- UDS screen on admission (if obtained) positive for alcohol, opioids other than prescribed for pain or maintenance opioids for OUD, or other substances of abuse
- History of psychedelic substance use in the preceding 5 years
- History (or active) cardiovascular disease (non-optimized coronary vascular disease, stable or unstable angina, new onset EKG abnormalities, congenital long QT syndrome, cardiac trauma involving surgical repair or CABG within 1 year)
- Screening blood pressure SBP >140 mmHg or DBP > 90 mmHg on three separate occasions
- Head trauma, traumatic brain injury, or concussion.
- Tachycardia defined as HR > 100, averaged over the previous 12 hours, excluding intra-operative care)
- History of dementia
- History of pre-existing neurological conditions (including TIA, stroke, epilepsy, MS, ALS, Guillain-Barre, Parkinson's)
- Patients on SSRIs, TCAs, MAO-Is, lithium, or other serotonergic medications, antipsychotics. Prohibited medications need to be discontinued at least 30 days prior to psilocybin dosing.
- Patients that received intra-operative intravenous methadone dosing > 20 mg.
- On vasopressors
- Hepatic impairment, mild to moderate, with Child-Pugh score ≥ 7
- Nicotine dependence, which would prevent the patient from staying in their room for the duration of the 8-hour psilocybin study period.
- On sedating IV infusions (propofol, ketamine, fentanyl, benzodiazepine, dexmedetomidine)
- History of suicidal or homicidal ideations within the last year
- History of seizure disorder
- Requiring restraints or active sitter
- Patients with a history of poorly controlled anxiety (GAD7 score of 10 or more), poorly controlled depression (PHQ9 score of 15 or more), panic disorder, paranoia, PTSD, bipolar disorder, any primary psychotic disorder like schizophrenia, schizoaffective disorder, or antisocial personality disorder; personal or first- or second-degree relative history of psychotic or bipolar I or II disorder
- History of Hallucinogen Use Disorder or Hallucinogen Persisting Perception Disorder (per DSM-V)
- Unable to consent (intubated/sedated)
- Intellectual disability
Where it is running
- UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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