NCT05317676|WithdrawnPhase 2DMCFDA Drug
Study Stopped
Sponsor suspending temporarily.
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Sponsor study identifier
interventional
0
1 country
1
Study Start
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Palmitoylethanolamide (PEA), a non-psychoactive cannabis compound derived from peanuts, egg yolks, and soybeans, is an Endogenous FA Amide produced in the body as a biological response and a repair mechanism in chronic inflammation and chronic pain. In animal and clinical trials, PEA has also shown evidence of pain reduction, sleep improvement, and increased joint mobility and function with minimal side-effects. The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2022
Actual (reported)April 8, 2022
Actual (reported)May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
3 month post-surgical Opioid use Questionnaire
Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with opioid prescription in chart
3 months
3 month post-surgical NSAID use Questionnaire
Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with NSAID prescription in chart
3 months
Pain Scores
3 months
300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge
1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge
2-month supply of PEA will be given upon discharge. 300mg will be taken twice a day in conjunction with discharge medications (opioid and NSAIDs).
2-month supply of placebo will be given upon discharge. Placebo will taken twice a day in conjunction with discharge medications (opioid and NSAIDs).
UC Irvine Medical Center
Orange, California, 92868, United States
Artukoglu BB, Beyer C, Zuloff-Shani A, Brener E, Bloch MH. Efficacy of Palmitoylethanolamide for Pain: A Meta-Analysis. Pain Physician. 2017 Jul;20(5):353-362.
Grotenhermen F. Cannabinoids and the endocannabinoid system. Cannabinoids.2006;1:10-14.
Martin-Sanchez E, Furukawa TA, Taylor J, Martin JL. Systematic review and meta-analysis of cannabis treatment for chronic pain. Pain Med. 2009 Nov;10(8):1353-68. doi: 10.1111/j.1526-4637.2009.00703.x. Epub 2009 Sep 1.
Ariana Nelson, MD
Associate Clinical Professor
0 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2022
First Posted
April 8, 2022
Study Start
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain
Pain Interference
3 months
Average Pain Scores
3 months
Functional Status
3 months
Post-Surgical Complications
3 months
Contact the study team to confirm eligibility.
Cabral GA, Griffin-Thomas L. Emerging role of the cannabinoid receptor CB2 in immune regulation: therapeutic prospects for neuroinflammation. Expert Rev Mol Med. 2009 Jan 20;11:e3. doi: 10.1017/S1462399409000957.
Calignano A, La Rana G, Giuffrida A, Piomelli D. Control of pain initiation by endogenous cannabinoids. Nature. 1998 Jul 16;394(6690):277-81. doi: 10.1038/28393.
Calignano A, La Rana G, Piomelli D. Antinociceptive activity of the endogenous fatty acid amide, palmitylethanolamide. Eur J Pharmacol. 2001 May 11;419(2-3):191-8. doi: 10.1016/s0014-2999(01)00988-8.
Esposito E, Paterniti I, Mazzon E, Genovese T, Di Paola R, Galuppo M, Cuzzocrea S. Effects of palmitoylethanolamide on release of mast cell peptidases and neurotrophic factors after spinal cord injury. Brain Behav Immun. 2011 Aug;25(6):1099-112. doi: 10.1016/j.bbi.2011.02.006. Epub 2011 Feb 25.
Luongo L, Guida F, Boccella S, Bellini G, Gatta L, Rossi F, de Novellis V, Maione S. Palmitoylethanolamide reduces formalin-induced neuropathic-like behaviour through spinal glial/microglial phenotypical changes in mice. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):45-54. doi: 10.2174/1871527311312010009.
Scuderi C, Steardo L. Neuroglial roots of neurodegenerative diseases: therapeutic potential of palmitoylethanolamide in models of Alzheimer's disease. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):62-9. doi: 10.2174/1871527311312010011.
Nau R, Djukic M, Spreer A, Ribes S, Eiffert H. Bacterial meningitis: an update of new treatment options. Expert Rev Anti Infect Ther. 2015;13(11):1401-23. doi: 10.1586/14787210.2015.1077700. Epub 2015 Aug 18.
Gabrielsson L, Mattsson S, Fowler CJ. Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Br J Clin Pharmacol. 2016 Oct;82(4):932-42. doi: 10.1111/bcp.13020. Epub 2016 Jun 29.
COBURN AF, GRAHAM CE, HANINGER J. The effect of egg yolk in diets on anaphylactic arthritis (passive Arthus phenomenon) in the guinea pig. J Exp Med. 1954 Nov 1;100(5):425-35. doi: 10.1084/jem.100.5.425.
Hesselink JM. Evolution in pharmacologic thinking around the natural analgesic palmitoylethanolamide: from nonspecific resistance to PPAR-alpha agonist and effective nutraceutical. J Pain Res. 2013 Aug 8;6:625-34. doi: 10.2147/JPR.S48653. eCollection 2013.
Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 9, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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