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Endocannabinoid
PEA for Knee Osteoarthritis
N/A
Waitlist Available
Led By Jennifer Klinedinst, PhD, MPH, RN
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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
protein changes
Secondary outcome measures
inflammatory markers
pain sensitivity
Side effects data
From 2018 Phase 2 trial • 17 Patients • NCT03066193100%
Fatigue/Drowsiness
100%
Feeling "high"
94%
Dry Mouth
81%
Difficulty concentrating
81%
Dizziness/Lightneadedness
69%
Headache
69%
Weakness, unsteadiness
69%
Anxiety
63%
Warmth or tingly feeling
63%
Gaps in memory
63%
Ataxia
56%
Lack of coordination
56%
Depersonalization
56%
Clumsiness
50%
Increased apetite
50%
Nausea
44%
Red eyes
44%
Exagerated sense or well being
44%
Heavy limbs/muscles
38%
Paranoia
38%
Sleep problems (insomnia)
38%
Blurry vision
38%
Decrease in apetite
31%
Mood changes
31%
Muscle aches/pains
25%
Stomach pain
25%
Diarrhea
25%
Panic attack
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dronabinol and Palmitoylethanolamide
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
688 Previous Clinical Trials
374,643 Total Patients Enrolled
3 Trials studying Osteoarthritis
135 Patients Enrolled for Osteoarthritis
Jennifer Klinedinst, PhD, MPH, RNPrincipal InvestigatorUniversity of Maryland, School of Nursing
Susan Dorsey, PhD, RNPrincipal InvestigatorUniversity of Maryland, School of Nursing
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with osteoarthritis in one or both of your knees.You have used opioids in the last month.You are allergic to oat, coconut, citrus, olive, or sunflower oils, or maltodextrin.You have a type of arthritis called inflammatory arthritis, like rheumatoid arthritis.You have had a knee injury within the last 6 months.You have experienced knee pain that is consistently rated at least 4 out of 10 on a pain scale over the past month.You have advanced kidney disease, unstable angina (chest pain), congestive heart failure, or are currently being treated for cancer (except skin cancer).
Research Study Groups:
This trial has the following groups:- Group 1: palmitoylethanolamide (PEA)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial accept elderly participants aged 85 and above?
"The scope of this clinical trial is exclusively reserved for patients aged 40 to 80; however, there are 38 additional studies available to those below 18 and 632 trials catering to individuals above 65."
Answered by AI
Are there any open enrollment opportunities for this medical trial?
"Clinicaltrials.gov states that the clinical trial is presently recruiting participants. This research was posted on February 2nd, 2023 and modified on the same day."
Answered by AI
How many people are participating in the experimentation of this clinical trial?
"Affirmatively, clinicaltrials.gov has the most recent information on this medical trial which was originally posted in February of 2023. The trial is actively recruiting and seeking out approximately 20 individuals at one site."
Answered by AI
What are the prerequisites for taking part in this investigation?
"The current trial is looking for 20 adults aged between 40 and 80 who are English speaking, have self-reported diagnoses of osteoarthritis in one or both knees which cause at least 4/10 pain on a 0-10 numeric rating scale. In addition to agreeing to abstain from all other treatments (except acetaminophen as needed) participants must pass an evaluation to sign consent."
Answered by AI
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