Endocannabinoids, Stress, Craving And Pain Effects Study

Phase

Condition

Opioid Use Disorder

Pain

Treatment

Palmitoylethanolamide

Placebo

Clinical Study ID

NCT05480072

2022P001440

Ages 18-65
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18 to 65
DSM-5 diagnosis of OUD
English speaking
Receiving either buprenorphine or methadone for treatment of opioid use disorder forat 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 toenrollment 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, vaginalrings, 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

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 withstudy participation and completion of study procedures [medical record review andhealth history form]
History of psychotic, bipolar and schizoaffective disorders [medical record reviewand health history form]
Lifetime psychiatric hospitalization or suicide attempt, as assessed by the healthhistory form
Recent history (within 2 years) of major depressive disorder [health history formand clinical interview]
Currently pregnant or breastfeeding (female only) [pregnancy test/ self-reported]
History of autoimmune or chronic inflammatory diseases [health history form] Currentuse of medications known to alter inflammatory and immune response [health historyform] 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 notlimited to, malignancy (and treatment for malignancy), HIV, immunological, endocrine (including uncontrolled diabetes or thyroid disease), renal, GI, or hematologicalabnormalities that are uncontrolled* [health history form and medical record review]

Study Design