Temporal Stability of Heavy Drinking Days and Drinking Reductions among Heavy Drinkers in the COMBINE Study

摘要

BackgroundRecently, the Food and Drug Administration (FDA) proposed to expand the options for primary endpoints in the development of medications for alcohol use disorder (AUD) to include either abstinence from alcohol or a non-abstinent outcome: no heavy drinking days (with a heavy drinking day defined as more than 3 drinks per day for women and more than 4 drinks per day for men [>3/>4 cutoff]). The FDA also suggested that 6 months would be the most appropriate length for a clinical trial to demonstrate the stability of this non-abstinent drinking outcome. However, few alcohol clinical trials have examined the stability of non-heavy drinking during and after treatment.