Pain ManagementPhase 1NCT07406828
Psilocybin After Trauma Surgery for Pain
A Phase 1 study testing Psilocybin (Usona Institute) and Postoperative analgesia in people with Pain Management and Postoperative Pain, run by Trent Emerick at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Pain Management, Postoperative Pain
- What is being tested?
- Psilocybin (Usona Institute) and Postoperative analgesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2027to Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Show all 28Show fewer
- 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
- Additional or anticipated surgeries within 7248 hrs of psilocybin administration
- Discharge from hospital pending within 24 hrs of psilocybin administration
- Any allergy to psilocybin or other inert substances in the product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dayana Alsamsam, BSPS, MSc contact
United States1 site
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Trent Emerick, MD, 412-692-2234, emericktd@upmc.edu
Amy Monroe, MPH, MBA, monroeal@upmc.edu
About this study
Official title: Single Dose Psilocybin for a Post-surgical Trauma Inpatient Population for Pain, Mood, and Opioid Use Disorder
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:
- Is a single psilocybin dose feasible to administer during postoperative hospitalization?
- Is psilocybin safe in this patient population?
- 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
Read the detailed description
This is an open-label pilot feasibility trial conducted at a single academic medical center. Fourteen participants receive a single oral dose of psilocybin during inpatient hospitalization following trauma surgery. Outcomes in the psilocybin group are compared with a retrospectively identified standard-of-care cohort of 56 trauma surgery patients with opioid use disorder, identified through electronic medical record review.
The standard-of-care cohort is selected using propensity score methods based on baseline characteristics, including age, sex, trauma diagnosis, psychiatric comorbidities, baseline medications, comorbid conditions, type of surgery, and baseline opioid consumption measured in morphine milligram equivalents.
No interim efficacy analyses are planned. After the first three participants have received psilocybin and completed the one-week follow-up assessments, the Data and Safety Monitoring Board reviews safety data to assess ongoing risk and determine whether study procedures should continue unchanged.
- Conditions
- Pain Management, Postoperative Pain
- Being tested
- Psilocybin (Usona Institute), Postoperative analgesia
- Keywords
- psilocybin, postoperative trauma, opioid, opioid use prevention, surgery, mushrooms, opioid adverse events
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 analgesiaDrug
Standard postoperative pain management, including multimodal analgesia and medications for opioid use disorder, provided per institutional clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Standard of Care | Active comparator | 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. Receives: Drug: Postoperative analgesia |
| Single Dose Psilocybin | Experimental | 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. Receives: Drug: Psilocybin (Usona Institute); Drug: Postoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment
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.
Measured: From enrollment and receipt of psilocybin to 3 days post-treatment.
Feasibility: Retention
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.
Measured: Day 5 post-treatment
Feasibility: Completion of One-Month PROs
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.
Measured: at 1-month post-treatment
Secondary outcomes (9)
Inpatient post-psilocybin acute pain scores (Visual Analogue Scale)
Inpatient post-psilocybin acute pain scores assessed by visual analogue scale pain scores (VAS scores 0-10). Postoperative pain intensity assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: at baseline and Days 1, 2, 3, 5, and 7 after psilocybin administration
Opioid consumption
Opioid consumption measured in morphine milligram equivalents (MME), collected from the electronic medical record during hospitalization and after discharge.
Measured: at baseline, and days 1, 2, 3, 5, and 7 after psilocybin administration.
Psilocybin Adverse side effects
Incidence and severity of adverse events following psilocybin administration, assessed through continuous clinical observation during the monitored dosing period, vital sign monitoring, and electronic medical record review.
Measured: measured at days 1, 2, 3, 5, 7 after psilocybin administration.
Generalized Anxiety Disorder (GAD)
Severity of anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 consists of 7 items scored from 0 to 3, yielding a total score range of 0 to 21. Scores of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively. Higher scores indicate greater anxiety severity.
Measured: at Baseline, and 1-month after psilocybin administration
Physical Function (PROMIS Physical Function)
Physical function assessed using the PROMIS Physical Function instrument. Scores are reported as standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better physical function.
Measured: at Baseline and 1-month after psilocybin administration
Resilience (Connor-Davidson Resilience Scale 10-Item Version)
Resilience assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). The CD-RISC-10 consists of 10 items evaluating an individual's ability to cope with stress and adversity. Each item is scored from 0 (not true at all) to 4 (true nearly all the time), yielding a total score range from 0 to 40. Higher total scores indicate greater resilience.
Measured: Baseline and 1-month after psilocybin administration
Depressive Symptoms (PHQ-9)
Patient-reported depressive symptom severity assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items scored from 0 to 3, yielding a total score range of 0 to 27. Higher scores indicate greater severity of depressive symptoms.
Measured: Baseline, and 1-month after psilocybin administration
PROMIS Pain Interference
Pain interference assessed using the PROMIS Pain Interference Short Form 8a. The instrument includes 8 items rated on a 5-point Likert scale from 1 (not at all) to 5 (very much). Raw scores are summed and converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater pain interference.
Measured: Baseline, and 1-month after psilocybin administration
Post-psilocybin opioid-related harms
Occurrence of opioid-related harms following psilocybin administration, including unintended hospital admissions related to opioid use, opioid overdose events (fatal or non-fatal), opioid use disorder relapse, and emergency department visits related to opioid adverse events. Assessed by participant self-report and/or medical record review.
Measured: Measured at 1-month after psilocybin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start31 Dec 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trent Emerick
- Sponsor type
- University, hospital or other
- Collaborators
- The Beckwith Institute
- Responsible party
- Sponsor-investigator, Trent Emerick, University of Pittsburgh
- Investigators
- Trent D. Emerick, Principal investigator, University of Pittsburgh / UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406828
- Sponsor's protocol ID
- STUDY24040071
- Status last verified
- Aug 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Psilocybin for a Post-surgical Trauma Inpatient Population for Pain, Mood, and Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07406828
- Acronym / sponsor ID
- STUDY24040071
- Conditions
- Pain Management, Postoperative Pain
- Keywords
- psilocybin, postoperative trauma, opioid, opioid use prevention, surgery, mushrooms, opioid adverse events
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Trent EmerickUniversity, hospital or other
- Collaborators
- The Beckwith Institute
- Study start
- 31 Dec 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is a single psilocybin dose feasible to administer during postoperative hospitalization?
- Is psilocybin safe in this patient population?
- 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
Detailed description
This is an open-label pilot feasibility trial conducted at a single academic medical center. Fourteen participants receive a single oral dose of psilocybin during inpatient hospitalization following trauma surgery. Outcomes in the psilocybin group are compared with a retrospectively identified standard-of-care cohort of 56 trauma surgery patients with opioid use disorder, identified through electronic medical record review.
The standard-of-care cohort is selected using propensity score methods based on baseline characteristics, including age, sex, trauma diagnosis, psychiatric comorbidities, baseline medications, comorbid conditions, type of surgery, and baseline opioid consumption measured in morphine milligram equivalents.
No interim efficacy analyses are planned. After the first three participants have received psilocybin and completed the one-week follow-up assessments, the Data and Safety Monitoring Board reviews safety data to assess ongoing risk and determine whether study procedures should continue unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Standard of Care | Active comparator | Drug: Postoperative analgesiaParticipants 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. |
| Single Dose Psilocybin | Experimental | Drug: Psilocybin (Usona Institute), Drug: Postoperative analgesiaParticipants 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 25 years old and ≤65 years old
- Inpatient
- English-speaking
- History of opioid use disorder as diagnosed by DSM-V
- Able to swallow capsules.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (Usona Institute)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. | Drug | Single Dose Psilocybin |
| Postoperative analgesiaStandard postoperative pain management, including multimodal analgesia and medications for opioid use disorder, provided per institutional clinical practice. | Drug | Postoperative Standard of Care, Single Dose Psilocybin |
Primary outcome
Feasibility: Recruitment
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Inpatient post-psilocybin acute pain scores (Visual Analogue Scale)
Time frame: at baseline and Days 1, 2, 3, 5, and 7 after psilocybin administration
Opioid consumption
Time frame: at baseline, and days 1, 2, 3, 5, and 7 after psilocybin administration.
Psilocybin Adverse side effects
Time frame: measured at days 1, 2, 3, 5, 7 after psilocybin administration.
Generalized Anxiety Disorder (GAD)
Time frame: at Baseline, and 1-month after psilocybin administration
Physical Function (PROMIS Physical Function)
Time frame: at Baseline and 1-month after psilocybin administration
Resilience (Connor-Davidson Resilience Scale 10-Item Version)
Time frame: Baseline and 1-month after psilocybin administration
Depressive Symptoms (PHQ-9)
Time frame: Baseline, and 1-month after psilocybin administration
PROMIS Pain Interference
Time frame: Baseline, and 1-month after psilocybin administration
Post-psilocybin opioid-related harms
Time frame: Measured at 1-month after psilocybin administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dayana Alsamsam, BSPS, MSc contact
Trent D. Emerick principal investigator
University of Pittsburgh / UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin (Usona Institute) and Postoperative analgesia in people with Pain Management and Postoperative Pain, run by Trent Emerick at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisha Maslanka, BS, CCRC (4128646779, maslankaaa@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment (time frame: From enrollment and receipt of psilocybin to 3 days post-treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 3 Nov 2026.