Endocannabinoids, Stress, Craving And Pain Effects (ESCAPE) Study

Study Overview
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Brief Summary
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Opioid use disorder (OUD) represents one of the most severe public health crises, with more than 2 million individuals affected in the United States. Existing treatments do not target and restore several key alterations triggering opioid craving and relapse, including increased response to stress, mood disturbances and greater sensitivity to pain, which are caused by prolonged exposure to opioids. This double-blind, randomized, placebo-controlled study will investigate the effects that palmitoylethanolamide (PEA), an endogenous molecule part of the endocannabinoid system available as a dietary supplement, exerts on these alterations and their underlying mechanisms, with the goal of identifying a novel therapeutic approach to reduce craving and prevent relapse in patients with OUD.

Official Title
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Investigating the Effects of Palmitoylethanolamide (PEA) on Stress, Craving and Pain in Opioid Use Disorder

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: Palmitoylethanolamide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of OUD Fluent in English Receiving either buprenorphine or methadone for treatment of opioid use disorder for at least 3 consecutive months prior to enrollment Agreeable to abstaining from using any cannabis or cannabidiol (CBD)-containing products for the duration of the trial For women of childbearing potential: agreeable to use one of the following: hormonal methods, such as birth control pills, patches, injections, vaginal rings, or implants barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm) intrauterine device (IUD) abstinence (no sex) Exclusion Criteria: Current diagnosis of moderate-to-severe cannabis use disorder and/or alcohol use disorder History of psychotic and schizoaffective disorders Currently pregnant or breastfeeding (female only) History of autoimmune or chronic inflammatory diseases Current use of medications known to alter inflammatory and immune response BMI >40

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEA 600 mg<br>PEA capsules(600 mg twice a day) will be administered for 21 days | Drug: Palmitoylethanolamide<br>* Palmitoyethanolamide (PEA) s a dietary supplement with anti-inflammatory and analgesic properties. Subjects will receive PEA (Levagen+) 600 capsules mg twice daily (BID) orally from Day 1 to Day 21<br>* Other names: Levagen+;|
| Placebo Comparator: Placebo<br>Placebo capsules(600 mg twice a day) will be administered for 21 days | Other: Placebo<br>* Participants will receive placebo matched to 600 mg PEA (Levagen+) capsules BID orally from Day 1 to Day 21<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress-induced opioid craving | changes from baseline in experimentally-provoked stress-induced craving ratings | day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palmitoylethanolamide, stress, craving, pain