An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder.
Am J Drug Alcohol Abuse
; 47(4): 467-475, 2021 07 04.
Article
in En
| MEDLINE
| ID: mdl-34092158
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Alcoholism
/
Pregabalin
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Am J Drug Alcohol Abuse
Year:
2021
Type:
Article
Affiliation country:
United States