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Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder.

BACKGROUND
Despite advances in development of pharmacotherapy for alcohol use disorder (AUD), the need for medication treatment that can be administered to actively drinking outpatients that promotes reduction in harmful alcohol consumption remains. 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 alcohol use disorder.


METHODS
Women and men (n = 40) 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) or placebo 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 predictors study arm, week, study arm by week interaction, and baseline outcome.


RESULTS
A significant interaction between study arm and week was found (F7,215 =3.33, p=.002) for proportion of HDD per week. A significant interaction between study arm and week was found (F7,215 =3.11, p=0.004) for PDA per week. 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 for the development of moderate-to-severe alcohol withdrawal (CIWA ≥ 13).


CONCLUSIONS
Gabapentin treatment rapidly titrated to a dose of 3600 mg per 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.