Pilot randomized placebo‐controlled clinical trial of high‐dose gabapentin for alcohol use disorder. (5th July 2021) - Mariani, John J.
Abstract: Background: Despite advances in the development of pharmacotherapy for alcohol use disorder (AUD), there remains a need for medications that can be administered to actively drinking outpatients to promote a reduction in harmful alcohol consumption. The primary aim of this pilot study was to determine whether high‐dose gabapentin (3600 mg/daily) is more effective than placebo in reducing harmful alcohol consumption in outpatients with AUD. Methods: Forty patients (27 men) who met DSM‐IV‐TR criteria for alcohol dependence and reporting at least 4 heavy drinking days (HDD) per week were recruited at a single site. Participants were actively drinking at study entry and received double‐blind gabapentin (3600 mg/day; n = 19) or placebo ( n = 20) for 8 weeks. Study medication was titrated over 5 days and administered in three divided doses (1200 mg three times per day). The proportion of HDD (primary outcome) and percent days abstinent (PDA; secondary outcome) were analyzed using generalized longitudinal mixed models with the predictors being study arm, week, study arm by week interaction, and corresponding baseline drinking measure. Results: There was a significant interaction between study arm and week for the proportion of HDD per week, F (7, 215) = 3.33, p = 0.002 . There was also a significant interaction between study arm and week for PDA per week, F (7, 215) = 3.11, p = 0.004. The overall retention rate was 67.5% with no significant difference in time‐to‐dropout between treatment groups. There were no serious adverse events. No participants were removed from the trial due to the development of moderate‐to‐severe alcohol withdrawal (CIWA‐Ar ≥ 13). Conclusions: Gabapentin treatment rapidly titrated to a dosage of 3600 mg/day is associated with a reduction in the proportion of HDD per week and an increase in PDA per week in actively drinking outpatients with AUD. High‐dose gabapentin is potentially a feasible approach to treating AUD and deserving of further study. Abstract : This pilot study (n = 40) evaluated high‐dose gabapentin (3600 mg/daily) as compared to placebo in reducing harmful alcohol consumption in outpatients with alcohol use disorder. Gabapentin was titrated over five days to the target dose of 1200 mg three times per day. Rapidly titrated high‐dose gabapentin treatment was associated with a reduction in the proportion of heavy drinking days per week.