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An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder.

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Title: An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder.
Authors: Mariani, John J. (AUTHOR), Pavlicova, Martina (AUTHOR), Choi, C. Jean (AUTHOR), Brooks, Daniel J. (AUTHOR), Mahony, Amy L. (AUTHOR), Kosoff, Zora (AUTHOR), Naqvi, Nasir (AUTHOR), Brezing, Christina (AUTHOR), Luo, Sean X. (AUTHOR), Levin, Frances R. (AUTHOR)
Source: American Journal of Drug & Alcohol Abuse. 2021, Vol. 47 Issue 4, p467-475. 9p.
Subjects: Alcoholism, Drug therapy, Pregabalin, Adults, Pilot projects
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 [ABSTRACT FROM AUTHOR]
Copyright of American Journal of Drug & Alcohol Abuse is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Label: Title
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  Data: An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder.
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  Data: <searchLink fieldCode="AR" term="%22Mariani%2C+John+J%2E%22">Mariani, John J.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pavlicova%2C+Martina%22">Pavlicova, Martina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Choi%2C+C%2E+Jean%22">Choi, C. Jean</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brooks%2C+Daniel+J%2E%22">Brooks, Daniel J.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mahony%2C+Amy+L%2E%22">Mahony, Amy L.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kosoff%2C+Zora%22">Kosoff, Zora</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Naqvi%2C+Nasir%22">Naqvi, Nasir</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brezing%2C+Christina%22">Brezing, Christina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Luo%2C+Sean+X%2E%22">Luo, Sean X.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Levin%2C+Frances+R%2E%22">Levin, Frances R.</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22American+Journal+of+Drug+%26+Alcohol+Abuse%22">American Journal of Drug & Alcohol Abuse</searchLink>. 2021, Vol. 47 Issue 4, p467-475. 9p.
– Name: Subject
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  Data: <searchLink fieldCode="DE" term="%22Alcoholism%22">Alcoholism</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+therapy%22">Drug therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Pregabalin%22">Pregabalin</searchLink><br /><searchLink fieldCode="DE" term="%22Adults%22">Adults</searchLink><br /><searchLink fieldCode="DE" term="%22Pilot+projects%22">Pilot projects</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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 [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of American Journal of Drug & Alcohol Abuse is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1080/00952990.2021.1901105
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        Text: English
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        PageCount: 9
        StartPage: 467
    Subjects:
      – SubjectFull: Alcoholism
        Type: general
      – SubjectFull: Drug therapy
        Type: general
      – SubjectFull: Pregabalin
        Type: general
      – SubjectFull: Adults
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      – SubjectFull: Pilot projects
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              Text: 2021
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