A randomized controlled trial of stepped treatment to reduce unhealthy alcohol use in patients with chronic liver disease

BACKGROUND AND AIMS: Unhealthy alcohol use is prevalent in chronic liver disease (CLD). This randomized controlled trial evaluated the efficacy of telehealth stepped alcohol treatment (SAT) in three healthcare systems. APPROACH AND RESULTS: Participants (N=157) with CLD and unhealthy alcohol use (>7 drinks/week or ≥4/day for women; >14/week or ≥5/day for men; or heavy episodic drinking, using timeline follow back), were enrolled at a safety-net and 2 Veterans Affairs hepatology clinics from 3/1/2022-2/28/2024. Participants were randomized to SAT (N=81; Step 1: three motivational interviewing sessions, Step 2: addiction medicine referral if no drinking reduction at month 3) or usual care (UC; N=76); evaluated at months 3 and 6. Alcohol use reduction was analyzed using bivariate tests and multivariable modeling. Baseline characteristics were: median age 61, 86% male, 48% with cirrhosis (37% decompensation), and 78% with alcohol use disorder. Compared to UC, SAT had no difference in percentage of alcohol use below moderate level (primary outcome) but had greater reduction in drinks/week from baseline to month 3 (estimate -0.66, P=0.03) and month 6 (estimate -0.67, P=0.03) (secondary outcome). The 6-month effect of SAT (vs UC) on alcohol use reduction remained significant (P=0.02), controlling for covariates. At month 6, 30-day abstinence rates were 29% for SAT and 18% for UC (P=0.14). Baseline motivation to reduce alcohol use was positively associated with treatment response. CONCLUSIONS: SAT was not superior on the primary outcome, yet reduced alcohol use more than UC at six months in this difficult-to-engage population and may be valuable in hepatology.