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