Effects of palmitoylethanolamide on opioid cravings and pain

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

This study is testing if a natural compound called palmitoylethanolamide can help reduce cravings and pain in people with opioid use disorder who are already on medication.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05480072 on ClinicalTrials.gov

What this trial studies

This interventional study aims to explore how palmitoylethanolamide (PEA), a natural compound in the endocannabinoid system, can affect stress, craving, and pain in individuals with opioid use disorder (OUD). It will be a double-blind, randomized, placebo-controlled trial involving participants who have been receiving stable doses of buprenorphine or methadone for at least three months. The study seeks to identify a novel therapeutic approach to reduce cravings and prevent relapse in patients suffering from OUD by targeting the underlying mechanisms of these conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a DSM-5 diagnosis of opioid use disorder who are stable on buprenorphine or methadone treatment.

Not a fit: Patients with moderate-to-severe cannabis use disorder, alcohol use disorder, or psychostimulant use disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option to help reduce cravings and prevent relapse in patients with opioid use disorder.

How similar studies have performed: While the specific use of palmitoylethanolamide for opioid cravings is novel, other studies have explored the endocannabinoid system's role in addiction and stress management.

Eligibility criteria

Inclusion Criteria:

* Age 18 to 65
* DSM-5 diagnosis of OUD
* English speaking
* Receiving either buprenorphine or methadone for treatment of opioid use disorder for at least 3 consecutive months prior to enrollment
* Receiving a stable dose of buprenorphine or methadone for the duration of the study
* Agreeable to abstaining from using any cannabis or CBD products two weeks prior to enrollment in the study, and 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:

* DSM-5 diagnosis of moderate-to-severe cannabis use disorder, alcohol use disorder, and/or psychostimulant use disorder \[medical record review and health history form\]
* Active, recurrent substance use within the last 3 months that will interfere with study participation and completion of study procedures \[medical record review and health history form\]
* History of psychotic, bipolar and schizoaffective disorders \[medical record review and health history form\]
* Lifetime psychiatric hospitalization or suicide attempt, as assessed by the health history form
* Recent history (within 2 years) of major depressive disorder \[health history form and clinical interview\]
* Currently pregnant or breastfeeding (female only) \[pregnancy test/ self-reported\]
* History of autoimmune or chronic inflammatory diseases \[health history form\] Current use of medications known to alter inflammatory and immune response \[health history form\] Raynaud's disease \[health history form\]
* BMI \>45
* Hepatic liver enzymes greater than 3x upper normal limit
* Vital signs: HR ≤60 or ≥100, SBP ≤90 or ≥160, DBP ≤50 or ≥100, RR \< 12 or \> 20
* Recent history of clinically significant medical conditions including, but not limited to, malignancy (and treatment for malignancy), HIV, immunological, endocrine (including uncontrolled diabetes or thyroid disease), renal, GI, or hematological abnormalities that are uncontrolled\* \[health history form and medical record review\]

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Conditions: Opioid Use Disorder, palmitoylethanolamide, stress, craving, pain