drugset / Trial / NCT05480072

Endocannabinoids, Stress, Craving And Pain Effects Study

NCT05480072

Phase 0 Completed 12 enrolled Brigham and Women's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-11-01
Primary completion
2025-01-14
Completion
2025-01-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Palmidrol Small molecule 600 mg Oral