Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Below Knee Fracture Fixation

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Irvine
• Collaborator: GE Nutrients Inc. (Gencor)
• Treatments: Palmidrol

Criteria

Inclusion Criteria:

• 18 years of age or older

• Has an isolated below knee orthopaedic injury without any neurovascular injury involvement

• Has an isolated active orthopaedic injury

• Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test on Day 1 before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.

• If females are of non-child bearing potential, they must be post-menopausal defined as: age > 55 with no menses within the past 12 months or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.

Exclusion Criteria:

• Less than 18 years of age

• Pregnant or Breastfeeding

• Allergic to cannabis

• History of chronic opioid use

• History of substance abuse

• History of chronic use of cannabis products of any kind

• Has multiple active orthopaedic injuries

• Has neurovascular injury associated with your orthopaedic injury

• History of a syndrome that causes chronic pain (i.e. fibromuscular dysplasia, complex pain syndrome)

• History of peripheral neuropathy

• History of diagnosed psychiatric illness

• ASA score of greater than 3

• Clinically significant unstable medical condition, including but not limited to cardiovascular, neurologic, psychiatric, endocrine, hepatic, and renal disorders.

• Allergy to palmitoylethanolamide (PEA) or its derivatives such as soy or eggs

• AST/ALT ≥3x ULN and/or bilirubin ≥2x ULN at screening.

• Abnormal creatinine or renal function abnormalities.

• Have end stage organ failure (Cardiac, Renal, or Hepatic)

• Currently undergoing addiction/detoxification therapy