Individuals with AUD consume fewer drinks per day when treated with apremilast.
nausea and vomiting, DSM-5
DISORDERS
A phase IIa double-blind, placebo-controlled POC study was conducted with the aim of clinically validating the effect of apremilast on decreasing alcohol intake in preclinical models of AUD. It was hypothesized that individuals with AUD who were treated with apremilast would consume significantly fewer standard drinks (~14 grams of alcohol per drink) per day over an 11-day period of ad libitum drinking than those treated with placebo. To further clarify whether any such effect was a result of reduction in heavy drinking specifically, numbers of heavy drinking days (4+ drinks/day for women, 5+ drinks/day for men) were similarly examined over this same period. Earlier PDE4 inhibitors like rolipram and ibudilast are associated with side effects, particularly nausea and vomiting, that may significantly reduce treatment retention (Study admission criteria specified non–treatment-seeking male and female paid volunteers 18 to 65 years of age with AUD of moderately severe or greater, as defined by the Diagnostic and Statistical Manual for Mental Disorders – Fifth Edition (DSM-5) criteria (The rate of study completion (84%) was equivalent across groups and is detailed in All participants completing the protocol (