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Palmitoylethanolamide for Chronic Pain

Phase 2

Waitlist Available

Research Sponsored by Navy Medical Center San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 8 weeks

Awards & highlights

Study Summary

This trial aims to see if a supplement called palmitoylethanolamide (PEA) can help reduce pain in patients with chronic inflammatory conditions. Participants will be split into two groups to take

Who is the study for?

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.Check my eligibility

What is being tested?

The study is testing if taking palmitoylethanolamide (PEA), a supplement, can reduce chronic pain better than a sugar pill (placebo). Participants will randomly receive either PEA or placebo and use it twice daily for 8 weeks to compare the effects on their pain and function.See study design

What are the potential side effects?

While the side effects are not detailed here, as PEA is a supplement rather than a pharmaceutical drug, potential side effects may include mild gastrointestinal symptoms such as stomach discomfort or nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 and 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 and 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain Level

Secondary outcome measures

Pain Catastrophizing Scale (PCS)

Pain interference and function

Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function)

Side effects data

From 2018 Phase 2 trial • 17 Patients • NCT03066193

100%

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%

Ataxia

63%

Gaps in memory

56%

Clumsiness

56%

Lack of coordination

56%

Depersonalization

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%

Study treatment Arm

Dronabinol and Palmitoylethanolamide

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PalmitoylethanolamideExperimental Treatment1 Intervention

Participants randomized to the experimental arm will receive the supplement Palmitoylethanolamide (PEA) at a dose of 600mg twice a day

Group II: PlaceboPlacebo Group1 Intervention

Participants randomized to the placebo arm will receive a visually identical placebo capsule

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Navy Medical Center San DiegoLead Sponsor

3 Previous Clinical Trials

395 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Palmitoylethanolamide received official endorsement from the FDA?

"The safety rating for Palmitoylethanolamide is estimated to be 2 by our team at Power on a scale of 1 to 3. This trial being in Phase 2 implies that there exists data supporting its safety, although efficacy evidence remains lacking."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"Per the details outlined on clinicaltrials.gov, recruitment for this trial is currently closed. Initially shared on March 1st, 2024 and last modified on February 15th, 2024; while enrollment is not active at present, there are a total of 408 alternative trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palmitoylethanolamide for Chronic Inflammatory Pain Conditions

2024. "Palmitoylethanolamide for Chronic Inflammatory Pain Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06273462.

All > American Chronic Pain