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Endocannabinoid

PEA for Knee Osteoarthritis

N/A
Waitlist Available
Led By Marc Hochberg, MD, MPH
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks

Summary

This trial will study if a dietary supplement (PEA) can reduce pain in adults with knee osteoarthritis and determine how it works. It will look at protein signatures, inflammation markers & neurobiological pathways.

Who is the study for?
This trial is for adults aged 40-80 with self-reported knee osteoarthritis, who speak English and can consent to the study. Participants must not take any pain medication other than acetaminophen and should have a knee pain level of at least 4 out of 10. Those using opioids, pregnant or breastfeeding women, people with certain allergies or inflammatory arthritis, recent knee injuries or surgeries are excluded.
What is being tested?
The study tests if taking PEA (a dietary supplement) for six weeks helps change protein signatures related to pain sensitivity in knee osteoarthritis patients. It's also checking if participants will stick to the regimen. Half will get PEA; the other half a placebo without knowing which one they're taking.
What are the potential side effects?
Specific side effects aren't listed but as a dietary supplement, PEA could potentially cause digestive discomfort, allergic reactions based on its ingredients like oat or coconut oils, or interact with other medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
protein changes
Secondary study objectives
inflammatory markers
pain sensitivity

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: palmitoylethanolamide (PEA)Experimental Treatment1 Intervention
Palmitoylethanolamide (PEA) is a lipid based endocannabinoid dietary supplement currently marketed.
Group II: PlaceboPlacebo Group1 Intervention
A similar size and shaped capsule containing maltodextrin will be used as a placebo comparator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
palmitoylethanolamide
2020
N/A
~120

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,226 Total Patients Enrolled
3 Trials studying Osteoarthritis
135 Patients Enrolled for Osteoarthritis
Marc Hochberg, MD, MPHPrincipal InvestigatorUniversity of Maryland, Baltimore
Jennifer Klinedinst, PhD, MPH, RNPrincipal InvestigatorUniversity of Maryland, School of Nursing

Media Library

Palmitoylethanolamide (PEA) (Endocannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05406726 — N/A
Osteoarthritis Research Study Groups: palmitoylethanolamide (PEA), Placebo
Osteoarthritis Clinical Trial 2023: Palmitoylethanolamide (PEA) Highlights & Side Effects. Trial Name: NCT05406726 — N/A
Palmitoylethanolamide (PEA) (Endocannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05406726 — N/A
~5 spots leftby Nov 2025
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