Status and phase
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Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
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:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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