Effects of kudzu extract on alcohol consumption among men and women seeking treatment for alcohol use disorder.

Background: We previously demonstrated that standardized kudzu extract (NPI-031) reduced drinking in a four-week trial among non-treatment-seeking men diagnosed with alcohol abuse or dependence. The present study assessed the safety and efficacy of eight weeks of kudzu among treatment-seeking men and women with alcohol use disorder (AUD). Methods: In this double-blind placebo-controlled study, nineteen individuals (12 M, 7 F; 27-65 years old) with AUD took either kudzu extract (750 mg isoflavones) or matched placebo daily, combined with weekly counseling for eight weeks. Twice weekly laboratory visits monitored alcohol consumption (via daily diaries and timeline follow-back), medication adherence (via urinary riboflavin), safety (via blood chemistry), and adverse events. Results: There were no significant differences in drinking at baseline, with 4.2 ± 0.7 heavy drinking days (HDDs) per week reported by the kudzu group (N = 9; 5 M, 4 F) and 4.7 ± 0.6 in the placebo group (N = 10; 7 M, 3 F). Medication adherence was excellent (>96%) with no adverse events or safety concerns noted. After 4 weeks of treatment, both groups decreased the number of HDDs per week by ~40%. Across the full 8-week treatment, the average reduction was 30% for kudzu extract and 44% for placebo. Conclusions: In contrast to results from prior studies among non-treatment-seeking young adult men, kudzu did not perform better than placebo in reducing drinking among a treatment-seeking sample of men and women with AUD. Taken together, these data suggest that kudzu may help to reduce binge drinking but may not provide additional benefits to individuals who are enrolled in an effective AUD treatment program.