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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Palmidrol

Criteria

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