So R, Nouso K, Matsushita S, et al. Efficacy and safety of a digital therapeutic for alcohol dependence: A multicenter, open-label, randomized controlled trial. Psychiatry Clin Neurosci. 2025;79(10):667-676. doi:10.1111/pcn.13874
This multicenter, open-label, parallel-group randomized controlled trial evaluated the efficacy and safety of ALM-003 in Japan. ALM-003 is a therapeutic smartphone application designed to support psychosocial treatment for adults with alcohol dependence who aim to reduce, rather than stop, drinking. Participants (n=278) were recruited from clinical sites and online advertisements and completed a four-week screening phase before randomization. During screening, participants were asked to record their daily alcohol use. This information allowed the researchers to exclude individuals who were likely to reduce consumption without intervention. To enter the 24-week treatment phase, participants had to meet predefined thresholds for alcohol intake, heavy drinking days (HDDs), and withdrawal severity, measured by the Clinical Institute Withdrawal Assessment for Alcohol–Revised (CIWA-Ar). The primary outcome was the change from baseline to Week 12 in the number of HDDs over 28 days, defined according to European Medicines Agency criteria (>60 g/day for men; >40 g/day for women). Compared with the control, ALM-003 significantly reduced HDDs at Week 12 and showed superiority on several responder outcomes, including achieving four or fewer HDDs per month, a 70% reduction in total alcohol consumption, and a two-level reduction in World Health Organization drinking risk level. The dropout rate was low (5.65%), and there were no differences in adverse events between groups. App engagement was sustained through Weeks 12 and 24. While the intervention showed a balance of efficacy, safety, and low training burden, its active therapeutic components remain unclear. Measures intended to capture mindfulness-related mechanisms did not differ between groups, underscoring the need for future mediation analyses and component-specific trials.