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Magic mushroom compound tested for Post-Surgery pain and opioid addiction

NCT ID NCT07406828

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2027

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

25 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

agnosia opiate dependence Pain, Postoperative

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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