Single Dose Psilocybin for a Post-surgical Trauma Inpatient Population for Pain, Mood, and Opioid Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Feasibility: Recruitment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 25 years old and ≤65 years old
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
Single Dose Psilocybin
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.
干预措施: Psilocybin (Usona Institute) (Drug)
Postoperative Standard of Care
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.
干预措施: Postoperative analgesia (Drug)
Single Dose Psilocybin
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.
干预措施: Postoperative analgesia (Drug)
结局指标
主要结局
Feasibility: Recruitment
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Inpatient post-psilocybin acute pain scores (Visual Analogue Scale)(at baseline and Days 1, 2, 3, 5, and 7 after psilocybin administration)
- Opioid consumption(at baseline, and days 1, 2, 3, 5, and 7 after psilocybin administration.)
- Psilocybin Adverse side effects(measured at days 1, 2, 3, 5, 7 after psilocybin administration.)
- Generalized Anxiety Disorder (GAD)(at Baseline, and 1-month after psilocybin administration)
- Physical Function (PROMIS Physical Function)(at Baseline and 1-month after psilocybin administration)
- Resilience (Connor-Davidson Resilience Scale 10-Item Version)(Baseline and 1-month after psilocybin administration)
- Depressive Symptoms (PHQ-9)(Baseline, and 1-month after psilocybin administration)
- PROMIS Pain Interference(Baseline, and 1-month after psilocybin administration)
- Post-psilocybin opioid-related harms(Measured at 1-month after psilocybin administration)
研究者
Trent Emerick
Associate Professor
University of Pittsburgh