Psilocybin After Trauma Surgery for Pain
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-65
SponsorTrent Emerick
About this trial
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
Eligibility criteria
Qualifiers
≥ 25 years old and ≤65 years old
Inpatient
English-speaking
History of opioid use disorder as diagnosed by DSM-V
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Psilocybin (Usona Institute)
- Postoperative analgesia
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Trent Emerick
Lead sponsor
University of Pittsburgh
Sponsor institution
The Beckwith Institute
Collaborator
Source ClinicalTrials.gov