Palmitoylethanolamide for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the supplement palmitoylethanolamide (PEA) can reduce pain and improve function in individuals with chronic inflammatory pain. Participants will be divided into two groups: one will take PEA, and the other will take a placebo for 8 weeks. The trial aims to determine if PEA is more effective than a placebo in managing pain. Individuals with chronic pain lasting more than 3 months, unresponsive to treatments like rest or medication, may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that palmitoylethanolamide is likely to be safe for humans?
Research has shown that palmitoylethanolamide (PEA) is generally safe for people. PEA, a natural fatty acid in the body, often helps with pain and swelling. Most people taking PEA experience only mild side effects, such as an upset stomach or diarrhea, if any. Serious side effects are rare. The presence of PEA in a mid-stage clinical trial indicates that earlier tests did not find major safety issues. If PEA were unsafe, it would not have reached this stage of testing.12345
Why do researchers think this study treatment might be promising?
Palmitoylethanolamide (PEA) is unique because it's a naturally occurring fatty acid that works by reducing inflammation and modulating the body's pain response. Unlike traditional treatments for chronic pain, such as opioids or NSAIDs, which can have significant side effects or addiction potential, PEA offers a potentially safer alternative. Researchers are excited about PEA because it targets the endocannabinoid system differently, potentially providing effective pain relief with fewer side effects.
What evidence suggests that palmitoylethanolamide might be an effective treatment for chronic pain?
Research shows that palmitoylethanolamide (PEA), which participants in this trial may receive, can help reduce various types of pain. Studies have found that it possesses properties that lower inflammation, benefiting conditions like osteoarthritis and fibromyalgia. PEA is a natural substance in the body that helps manage pain and swelling. Some individuals have reported experiencing less chronic pain after taking PEA supplements. Although more research is needed to confirm its effectiveness, early findings are promising for those seeking alternative pain relief methods.12346
Are You a Good Fit for This Trial?
This trial is for people who have been dealing with chronic inflammatory pain for more than 3 months, which hasn't improved with basic treatments like rest or over-the-counter meds. The pain should be at least a 5 out of 10 in intensity. It's not suitable for those with severe food allergies, including nuts, eggs, or soy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Palmitoylethanolamide (PEA) or a placebo for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Palmitoylethanolamide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Navy Medical Center San Diego
Lead Sponsor