Magic mushroom compound tested for Post-Surgery pain and opioid addiction
NCT ID NCT07406828
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This early-stage trial will give a single 10 mg dose of psilocybin to 70 adults recovering from trauma surgery who also have opioid use disorder. Researchers want to see if it's safe and practical to give psilocybin in the hospital, and how it affects pain, mood, and opioid use over the next month. The study is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- psilocybin (a psychedelic drug)
- What this could lead to
- If it works, this could point toward a new way to help trauma surgery patients with opioid use disorder manage pain and reduce opioid dependence.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety and feasibility, not effectiveness. The results may not apply to broader populations, and psilocybin can cause intense psychological effects requiring careful monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2027
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥ 25 years old and ≤65 years old 2. Inpatient 3. English-speaking 4. History of opioid use disorder as diagnosed by DSM-V 5. Able to swallow capsules. 6. 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. Exclusion Criteria: 1. Pregnancy. Women of child-bearing potential need to have a negative pregnancy test result at screening and baseline. 2. 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. 3. Breastfeeding 4. Patients receiving concurrent ketamine therapy or who have received ketamine therapy during the trauma admission. 5. 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 6. History of psychedelic substance use in the preceding 5 years 7. 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) 8. Screening blood pressure SBP \>140 mmHg or DBP \> 90 mmHg on three separate occasions 9. Head trauma, traumatic brain injury, or concussion. 10. Tachycardia defined as HR \> 100, averaged over the previous 12 hours, excluding intra-operative care) 11. History of dementia 12. History of pre-existing neurological conditions (including TIA, stroke, epilepsy, MS, ALS, Guillain-Barre, Parkinson's) 13. 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. 14. Patients that received intra-operative intravenous methadone dosing \> 20 mg. 15. On vasopressors 16. Hepatic impairment, mild to moderate, with Child-Pugh score ≥ 7 17. Nicotine dependence, which would prevent the patient from staying in their room for the duration of the 8-hour psilocybin study period. 18. On sedating IV infusions (propofol, ketamine, fentanyl, benzodiazepine, dexmedetomidine) 19. History of suicidal or homicidal ideations within the last year 20. History of seizure disorder 21. Requiring restraints or active sitter 22. 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 23. History of Hallucinogen Use Disorder or Hallucinogen Persisting Perception Disorder (per DSM-V) 24. Unable to consent (intubated/sedated) 25. Intellectual disability 26. Additional or anticipated surgeries within 7248 hrs of psilocybin administration 27. Discharge from hospital pending within 24 hrs of psilocybin administration 28. Any allergy to psilocybin or other inert substances in the product
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
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