Dataset Information

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

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.

SUBMITTER: Mariani JJ

PROVIDER: S-EPMC8462978 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Mariani John J JJ Pavlicova Martina M Basaraba Cale C Mamczur-Fuller Agnieszka A Brooks Daniel J DJ Bisaga Adam A Carpenter Kenneth M KM Nunes Edward V EV Levin Frances R FR

Alcoholism, clinical and experimental research 20210705 8

<h4>Background</h4>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.<h4>Methods</h4>Forty patients (27 men) who met DSM ...[more]

PMID: 34120336

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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