Psilocybin for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a single dose of psilocybin, a compound found in certain mushrooms, is safe and beneficial for individuals with a history of opioid use recovering from trauma surgery. The trial aims to determine if psilocybin can be safely administered in a hospital setting and how it affects pain, opioid use, anxiety, and depression during recovery. Participants will receive either standard pain management or a single dose of psilocybin alongside standard care. Those diagnosed with opioid use disorder and recovering from recent trauma surgery may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a unique opportunity to be among the first to receive this novel treatment.
Will I have to stop taking my current medications?
If you are taking SSRIs, TCAs, MAO-Is, lithium, or other serotonergic medications, you will need to stop them at least 30 days before taking psilocybin in this trial.
Is there any evidence suggesting that psilocybin is likely to be safe for humans?
Research has shown that psilocybin is generally safe for people. Studies have found that a single oral dose can be administered safely. It has been tested in various situations and may help with pain and mood issues. Most people tolerate it well, though some might experience mild side effects like headaches or nausea.
In studies involving individuals with chronic pain, psilocybin did not cause any immediate harm. While its effectiveness for pain remains unclear, its safety in similar contexts suggests it poses little risk for short-term use. This is particularly important for those considering it after surgery, especially individuals with opioid use disorder.
Overall, the evidence suggests psilocybin is safe in controlled settings, but individual experiences can vary.12345Why do researchers think this study treatment might be promising?
Most treatments for postoperative pain involve standard pain management techniques, including multimodal analgesia and medications for opioid use disorder. However, psilocybin is unique because it is derived from psychedelic mushrooms and offers a completely different approach by potentially modulating perception and emotional processing, which might help reduce pain perception. Researchers are excited about psilocybin because it works on serotonin receptors in the brain, offering a novel mechanism of action compared to traditional painkillers. This could lead to effective pain management with possibly fewer side effects and less risk of addiction than opioids.
What evidence suggests that psilocybin might be an effective treatment for postoperative pain?
Research shows that psilocybin, a substance in certain mushrooms, might help with pain relief. Some studies have found that just one dose of psilocybin can quickly and effectively reduce pain in various conditions. However, other research suggests it might not change pain sensitivity, meaning it doesn't alter how the body feels pain. Psilocybin may also help lower anxiety and depression, which could indirectly ease pain by boosting mood. In this trial, participants will receive either a single dose of psilocybin or standard postoperative care to evaluate its effects on pain after surgery. While researchers continue to study its effects, these findings suggest it could be a promising treatment.13467
Who Is on the Research Team?
Trent D. Emerick
Principal Investigator
University of Pittsburgh / UPMC
Are You a Good Fit for This Trial?
This trial is for English-speaking adults aged 25-65 recovering from trauma surgery who have a history of opioid use disorder. They must be able to swallow capsules and receive psilocybin within three days post-surgery during their hospital stay.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of psilocybin during their postoperative inpatient stay
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study tests the feasibility and safety of a single oral dose of psilocybin given to patients with opioid use disorder after trauma surgery. It will assess its effects on pain, opioid consumption, anxiety, and depression post-discharge.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Trent Emerick
Lead Sponsor
The Beckwith Institute
Collaborator
Citations
NCT07406828 | Psilocybin After Trauma Surgery for Pain
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 ...
Single-dose psilocybin rapidly and sustainably relieves ...
These results suggest that a single dose of psilocybin induces a rapid and durable analgesic effect in two distinct conditions associated with ...
Psilocybin has no immediate or persistent analgesic effect in ...
Notably, our results showed no change in mechanical sensitivity in either naïve or injury models, suggesting psilocybin may not affect pain thresholds ...
Psilocybin for Postoperative Pain · Info for Participants
The study tests the feasibility and safety of a single oral dose of psilocybin given to patients with opioid use disorder after trauma surgery. It will assess ...
Psilocybin After Trauma Surgery for Pain - ClinicalTrials.Veeva
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 ...
Psilocybin and Chronic Pain: A New Perspective for Future ...
Conclusions: Psilocybin shows promise as a multidimensional therapy for chronic pain, addressing both sensory and affective components. However, ...
No evidence of immediate or persistent analgesic effect ...
The psychedelic psilocybin may have lasting therapeutic effects for patients with chronic pain syndromes. Some preclinical data suggest ...
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