Citation

Miyake N, So R, Kariyama K, Itagaki Y, Yamagishi T, Wakuta A, Nishimura M, Murakami S, Ogawa M, Takebayashi Y, Sunami T, Yumoto Y, Ito M, Maesato H, Matsushita S, Nouso K. Gen. Hosp. Psychiatry 2024; 90: 68-75.

Copyright

(Copyright © 2024, Elsevier Publishing)

DOI

10.1016/j.genhosppsych.2024.07.003

PMID

39024702

Abstract

BACKGROUND: Addressing the limited access to treatments for alcohol dependence, we developed ALM-002, a therapeutic application to be "prescribed" for non-abstinence-oriented treatment in internal medicine settings. Our objective was to preliminarily assess the efficacy and safety of ALM-002.

METHODS: In a multicenter, open-label randomized controlled trial, participants aged ≥20 with alcohol dependence and daily alcohol consumption exceeding 60 g for men and 40 g for women, without severe complications, were randomly assigned to either the intervention group using ALM-002 or the treatment-as-usual control group. Participant in both groups received individual face-to-face sessions by physicians at weeks 0, 4, 8, and 12. The primary endpoint was the change in heavy drinking days (HDDs) from week 0 to week 12. A mixed model for repeated measures was employed.

RESULTS: We enrolled 43 participants: 22 in the intervention group and 21 in the control group. A significant reduction in HDDs every 4 weeks from week 0 to week 12 was observed, with a between-group difference of -6.99 days (95% CI: -12.4 to -1.6 days, standardized mean difference: -0.80).

CONCLUSIONS: These results indicate the potential of ALM-002 as a viable treatment for alcohol dependence. Further studies are needed to evaluate the clinical potential of ALM-002.

Language: en

Keywords

Alcohol use disorder; Alcohol dependence; Digital therapeutics; Heavy drinking; Mobile applications