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ABSTRACT
Background: There is a need for alcohol use disorder (AUD) pharmacotherapy that can be administered to actively drinking outpatients. Pregabalin, a gabapentoid anticonvulsant, has preliminary evidence supporting effects on alcohol withdrawal and AUD.
Objectives: To evaluate the safety, tolerability, and optimal dosing of pregabalin for treating AUD.
Methods: In an open-label, 8-week, outpatient trial of eighteen adults (nine women) with AUD, participants were titrated to 600 mg/day (or the maximum tolerated dose) over 3 weeks and then maintained for 5 weeks.
Results: The majority (11/14, 78.6%) of participants with at least one-week of medication exposure achieved a maximum dose of 600 mg/day. Mean retention was 6.8 weeks (SD = 2.6). Eighty percent (12/15) of participants with post-enrollment data reported any adverse effects during the trial; and for those reporting adverse effects the most common were drowsiness (33.3%, 4/12), and fogginess (25%, 3/12), dizziness (25%, 3/12), and insomnia (25%, 3/12). Two participants discontinued study medication due to adverse effects and one had a dose reduction. Mean Heavy Drinking Days (HDD)/week decreased significantly by 3.43 days (SD = 2.47; median (IQR) = 4.00 (1.00 to 5.50)); Wilcoxon signed rank test statistic ((S) = 49.5, p = .0006). Mean proportion of HDD significantly decreased on average by 48.7% (SD = 35.1%; median (IQR) = 57.1% (14.3% to 78.6%)). The proportion of abstinent days increased significantly on average by 36.1% (SD = 35.0%; median (IQR) = 17.9% (14.3% to 75.0%); S = 49.5, p = .0005).
Conclusions: Pregabalin treatment of AUD appears to be safe and well tolerated in doses up to 600 mg per day.
Trial Registration: clinicaltrials.gov identifier: NCT03256253
Acknowledgements
Dr Mariani had full access to all of the data of the study and takes full responsibility for the integrity of the data and for the accuracy of the data analysis. We would like to thank the staff of the Substance Treatment and Research Service (STARS) of the Columbia University Irving Medical Center/New York State Psychiatric Institute for their clinical support.
Declaration of interests
Dr Mariani has served as a consultant to Indivior and Novartis. Dr Levin receives grant support from the NIDA, SAMHSA and US World Meds and has been an unpaid member of a Scientific Advisory Board for Alkermes, Novartis and US WorldMeds. Drs Pavlicova, Brezing, Naqvi, and Luo reported no biomedical financial interests or potential conflicts of interest. Also, Ms Choi, Ms Mahony, Mr Brooks, and Ms Kosoff reported no biomedical financial interests or potential conflicts of interest. The authors alone are responsible for the content and writing of this paper.