Abstract
AIM: Digital therapeutics (DTx) is an emerging treatment modality for enhancing psychosocial interventions via software programs, such as smartphone applications (apps). We developed a DTx named ALM-003 to support treatment for people with alcohol dependence who are pursuing reduced drinking goals. ALM-003 was designed to promote behavioral change through daily self-monitoring with personalized feedback, interactive psychoeducational modules, and automated treatment support tools for both patients and physicians. In this multicenter, open-label, randomized controlled trial (RCT), we aimed to evaluate the efficacy and safety of ALM-003 in various clinical settings. METHODS: In this RCT, participants with alcohol dependence without serious physical, mental, or social problems due to excessive drinking, and exhibiting high or very high drinking risk levels were randomized into an intervention group (psychosocial intervention enhanced by ALM-003) or a control group (psychosocial intervention with a basic drinking diary app) for 24 weeks. The primary outcome was the change in the number of heavy drinking days (HDDs) over 28 days (Week 0 to Week 12). RESULTS: Data analysis of the primary outcome for 136 intervention and 142 control participants was performed. Baseline HDDs were 23.2 and 23.1 days/28 days in the intervention and control groups, respectively. [Correction added on 3 September 2025, after first online publication: The values of the baseline HDDs in the preceding sentence have been corrected from '19.4 and 19.1 days' to '23.2 and 23.1 days'.] At Week 12, the intervention and control groups showed a reduction in HDDs of -12.2 and -9.5 days from baseline, with a between-group difference of -2.79 days/28 days (95% confidence interval: -4.67 to -0.90; P = 0.004). Adverse events occurred in 32.9% of participants in the intervention group and 33.6% in the control group. No adverse events were attributed to app use. CONCLUSION: ALM-003 demonstrated efficacy in reducing heavy drinking days among people with alcohol dependence at a high or very high drinking risk. CLINICAL TRIAL REGISTRATION: The trial design was prospectively registered with the Japan Registry of Clinical Trials (jRCT) (https://jrct.niph.go.jp/). The trial identifier is jRCT2032220560.