An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder. (4th July 2021)

• Record Type: Journal Article
• Authors: Mariani, John J.; Pavlicova, Martina; Choi, C. Jean; Brooks, Daniel J.; Mahony, Amy L.; Kosoff, Zora; Naqvi, Nasir; Brezing, Christina; Luo, Sean X.; Levin, Frances R.
• Is Part Of: American journal of drug and alcohol abuse. Volume 47:Number 4(2021)
• Page Start: 467
• Page End: 475
• Publication Date: 2021-07-04
• Subjects: Pregabalin -- pharmacotherapy -- alcohol use disorder; Drug abuse -- Treatment -- Periodicals; Alcoholism -- Treatment -- Periodicals; Substance-abuse -- Treatment -- Periodicals; Alcoholism -- Periodicals; Substance-Related Disorders -- Periodicals; 616.86
• DOI: 10.1080/00952990.2021.1901105
• Languages: English
• ISSNs: 0095-2990

Abstract

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