Psilocybin After Trauma Surgery for Pain
This study is looking at whether a single dose of psilocybin (from Usona Institute) is safe and practical for adults aged 25 to 65 who have opioid use disorder (OUD) and are recovering from trauma surgery. Participants will receive one oral dose of psilocybin during their hospital stay after surgery. The study wants to see if giving psilocybin is feasible, if it's safe for this group of patients, and how it might affect their pain, opioid use, anxiety, and depression after they leave the hospital. The main goals are to check how easy it is to recruit participants, keep them in the study, and get them to complete follow-up assessments.
- Study design
- This is an open-label (meaning both you and the study staff know what treatment you receive) pilot study at one medical center, involving 14 participants who receive psilocybin.
- What's involved
- You would receive one oral dose of psilocybin during your inpatient hospitalization and complete assessments of pain, mood, and opioid use during your recovery.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for feasibility of recruitment up to 3 days post-treatment, for retention up to Day 5 post-treatment, and for completion of patient-reported outcomes (PROs) at 1-month post-treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Psilocybin After Trauma Surgery for Pain
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Trent D. Emerick · PRINCIPAL_INVESTIGATOR · University of Pittsburgh / UPMC
Who to contact
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What this trial measures
- Feasibility: RecruitmentFrom 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: RetentionDay 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required study assessments through follow-up day 5, divided by the number of individuals enrolled, treated, and not withdrawn.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 PROsat 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.