Psilocybin for Lower Back 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 in certain mushrooms, can increase awareness of body sensations and improve outcomes for people with chronic low back pain in physical therapy. Researchers are testing both low and moderate doses of psilocybin against a placebo to determine if it reduces pain and enhances therapy results. Ideal candidates for this trial are individuals who have experienced low back pain affecting daily activities for at least three months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking pain management solutions.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking certain medications, including serotonergic medications (like SSRIs and SNRIs) and medications affecting pain (like opioids and gabapentinoids), to participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that psilocybin, the treatment used in this study, is generally safe for people. Studies on low doses of psilocybin have found that a single dose does not cause serious mental or physical harm in healthy individuals, indicating most people handle it well.
For moderate doses, research also supports its safety. Studies indicate it has low toxicity and is generally well-tolerated. While some people experience strong positive effects, any negative effects are usually mild and short-lived.
Overall, existing evidence suggests that psilocybin, at both low and moderate doses, is safe for human use.12345Why are researchers excited about this trial's treatments?
Unlike typical treatments for lower back pain, which often include medications like NSAIDs or opioids, psilocybin offers a fresh approach by targeting the brain's serotonin receptors in a novel way. Researchers are intrigued by its potential to not only relieve pain but also address the psychological aspects of chronic pain, such as anxiety and depression. This dual-action mechanism could provide faster relief and improve overall well-being without the addictive risks associated with traditional painkillers. The use of low-dose (10 mg) and moderate-dose (25 mg) psilocybin could also reveal different levels of effectiveness and safety, offering more tailored treatment options for patients.
What evidence suggests that psilocybin might be an effective treatment for chronic low back pain?
Research has shown that psilocybin, a substance found in certain mushrooms, might help with long-lasting pain. In some studies, participants reported a significant decrease in pain after using psilocybin, with effects lasting for months. Psilocybin may help the brain change and adapt, potentially improving pain perception. Animal studies have indicated that even a single dose can lessen pain from nerve injuries. While more research is needed, these findings suggest psilocybin could provide relief for those with chronic low back pain. This trial will compare the effects of low-dose psilocybin (10 mg) and moderate-dose psilocybin (25 mg) to a placebo (niacin) to evaluate its potential benefits for chronic low back pain.26789
Who Is on the Research Team?
Joao De Aquino, M.D.
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for adults with ongoing lower back pain who are currently in physical therapy. Participants must be able to safely receive psilocybin and agree to follow-up assessments. People with certain psychological conditions, heart problems, or those on conflicting medications cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of psilocybin or placebo followed by a standardized course of physical therapy
Follow-up
Participants are monitored for changes in interoceptive awareness, pain, and functional disability
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study tests if a single dose of psilocybin (either 25 mg or 10 mg) can enhance body sensation awareness during physical therapy for chronic low back pain, compared to Niacin (100 mg), which serves as a control.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Citations
Psilocybin and Chronic Pain: A New Perspective for Future ...
Following three administrations of psilocybin mushrooms, her pain scores fell dramatically to near zero and remained stable for nine months. ...
Psilocybin as a novel treatment for chronic pain - Askey
By promoting neuroplasticity, psilocybin could provide long-lasting improvements in pain-related affective and sensory dysfunction in ...
Psilocybin targets brain circuits to relieve pain
In studies using mice with chronic nerve injury and inflammatory pain, researchers found that a single dose of psilocybin reduced both pain and ...
Psilocybin Therapy for Chronic Low Back Pain
This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively.
Psilocybin in Chronic Low Back Pain and Depression
This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression ...
Psilocybin-Assisted Physical Therapy in Chronic Low Back ...
The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness ...
Psilocybin Microdosing: Science, Safety, Transformation Guide
Meta-analyses indicate that medium-to-high doses, typically in the range of 10 mg to over 30 mg of psilocybin, produce the strongest and most ...
Psilocybin and chronic neuropathic pain: a systematic review
These tools enabled a detailed quantitative analysis of psilocybin's potential efficacy as a therapy for chronic pain. As a secondary outcome, ...
Research Articles: Psilocybin Safety in Healthy Participants
These findings suggest that a single administration of psilocybin is safe with regard to acute psychological and physical harm in healthy participants in a ...
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