Efficacy and tolerability of baclofen in a U.S. community population with alcohol use disorder: a dose-response, randomized, controlled trial
| العنوان: | Efficacy and tolerability of baclofen in a U.S. community population with alcohol use disorder: a dose-response, randomized, controlled trial |
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| المؤلفون: | Robert Gallop, Alexei B. Kampov-Polevoy, Robyn Jordan, James C. Garbutt, Cort A. Pedersen, Melissa Stansbury, Laura Willing |
| المصدر: | Neuropsychopharmacology |
| بيانات النشر: | Springer Science and Business Media LLC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Male, Baclofen, medicine.medical_specialty, medicine.drug_class, Drug development, Alcohol use disorder, Placebo, Article, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacotherapy, Double-Blind Method, Randomized controlled trial, law, Internal medicine, medicine, Humans, Pharmacology, business.industry, Alcohol dependence, Middle Aged, medicine.disease, 030227 psychiatry, Alcoholism, Psychiatry and Mental health, Treatment Outcome, Tolerability, chemistry, Sedative, Female, Psychiatric disorders, business, 030217 neurology & neurosurgery |
| الوصف: | Identification of new medications for alcohol use disorder (AUD) is important for improving treatment options. Baclofen, a GABABagonist, has been identified as a potential pharmacotherapy for AUD. In a 16-week double-blind, randomized, placebo-controlled trial, we investigated 30 and 90 mg/day of baclofen compared to placebo and examined effects of dose, sex, and level of pretreatment drinking. One hundred and twenty participants with DSM-IV alcohol dependence (age 46.1 (sd = 10.1) years, 51.7% male) were randomized after exclusion for unstable medical/psychiatric illness and/or dependence on drugs other than nicotine. Seventy-three participants completed the trial. A main effect of baclofen was found [%HDD (F(2,112) = 4.16,p = 0.018,d = 0.51 95%CI (0.06–0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68,p = 0.028,d = 0.49 95%CI (0.04–0.93), 12.9 more abstinent days)] and was driven by the 90 mg/day dose. A sex × dose interaction effect was present for both %HDD (F(2,110) = 5.48,p = 0.005) and %ABST (F(2,110) = 3.19,p = 0.045). Men showed a marginally positive effect for 90 mg/day compared to PBO (%HDD t(110) = 1.88,p = 0.063,d = 0.36 95%CI (−0.09–0.80), 15.8 fewer HDD days; %ABST t(110) = 1.68 (p = 0.096,d = 0.32 95%CI (−0.12–0.76), 15.7 more ABST)) with no effect for 30 mg/day. Women showed a positive effect for 30 mg/day (%HDD, t(110) = 3.19,p = 0.002,d = 0.61 95%CI (0.16–1.05), 26.3 fewer HDD days; %ABST t(110) = 2.73,p = 0.007,d = 0.52 95%CI (0.07–0.96), 25.4 more ABST days) with marginal effects for 90 mg/day on %ABST (p = 0.06) with drop-outs/dose reduction from sedative side-effects of 59% in women at 90 mg/day compared to 5% for men. These findings support the hypothesis that baclofen has efficacy in AUD and suggest that dose and sex be further explored as potential moderators of baclofen response and tolerability. |
| تدمد: | 1740-634X 0893-133X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cc52acedb2585c7abd5ebd417136c01e https://doi.org/10.1038/s41386-021-01055-w |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....cc52acedb2585c7abd5ebd417136c01e |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 1740634X 0893133X |
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