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The primary aim of this pilot study was to determine whether high\u2010dose gabapentin (3600\u00a0mg\/daily) is more effective than placebo in reducing harmful alcohol consumption in outpatients with AUD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Forty patients (27 men) who met DSM\u2010IV\u2010TR criteria for alcohol dependence and reporting at least 4\u00a0heavy drinking days (HDD) per week were recruited at a single site. Participants were actively drinking at study entry and received double\u2010blind gabapentin (3600\u00a0mg\/day; <jats:italic>n<\/jats:italic>\u00a0=\u00a019) or placebo (<jats:italic>n<\/jats:italic>\u00a0=\u00a020) for 8\u00a0weeks. Study medication was titrated over 5\u00a0days and administered in three divided doses (1200\u00a0mg three times per day). The proportion of HDD (primary outcome) and percent days abstinent (PDA; secondary outcome) were analyzed using generalized longitudinal mixed models with the predictors being study arm, week, study arm by week interaction, and corresponding baseline drinking measure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There was a significant interaction between study arm and week for the proportion of HDD per week, <jats:italic>F<\/jats:italic> (7, 215)\u00a0=\u00a03.33, <jats:italic>p<\/jats:italic>\u00a0=\u00a00.002 . There was also a significant interaction between study arm and week for PDA per week, <jats:italic>F<\/jats:italic> (7, 215)\u00a0=\u00a03.11, <jats:italic>p<\/jats:italic>\u00a0=\u00a00.004. The overall retention rate was 67.5% with no significant difference in time\u2010to\u2010dropout between treatment groups. There were no serious adverse events. No participants were removed from the trial due to the development of moderate\u2010to\u2010severe alcohol withdrawal (CIWA\u2010Ar\u00a0\u2265\u00a013).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Gabapentin treatment rapidly titrated to a dosage of 3600\u00a0mg\/day is associated with a reduction in the proportion of HDD per week and an increase in PDA per week in actively drinking outpatients with AUD. High\u2010dose gabapentin is potentially a feasible approach to treating AUD and deserving of further study.<\/jats:p><\/jats:sec>","DOI":"10.1111\/acer.14648","type":"journal-article","created":{"date-parts":[[2021,6,13]],"date-time":"2021-06-13T02:46:01Z","timestamp":1623552361000},"page":"1639-1652","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Pilot randomized placebo\u2010controlled clinical trial of high\u2010dose gabapentin for alcohol use disorder"],"prefix":"10.1111","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9535-7744","authenticated-orcid":false,"given":"John J.","family":"Mariani","sequence":"first","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute New York NY USA"},{"name":"Department of Psychiatry Columbia University Irving Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Pavlicova","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Mailman School of Public Health Columbia University New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cale","family":"Basaraba","sequence":"additional","affiliation":[{"name":"Mental Health Data Science Division New York State Psychiatric Institute New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnieszka","family":"Mamczur\u2010Fuller","sequence":"additional","affiliation":[{"name":"Supervised Release Program New York City Criminal Justice Agency New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J.","family":"Brooks","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Bisaga","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute New York NY USA"},{"name":"Department of Psychiatry Columbia University Irving Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth M.","family":"Carpenter","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute New York NY USA"},{"name":"Department of Psychiatry Columbia University Irving Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward V.","family":"Nunes","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute New York NY USA"},{"name":"Department of Psychiatry Columbia University Irving Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances R.","family":"Levin","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute New York NY USA"},{"name":"Department of Psychiatry Columbia University Irving Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,5]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"727","article-title":"Differential effect of gabapentin on neuronal and muscle calcium currents","volume":"297","author":"Alden K.J.","year":"2001","journal-title":"Journal of Pharmacology and Experimental Therapeutics"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.0249"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e3181aba6a4"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10101436"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.26345"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.49.3.739"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1998.tb01357.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2005.10.008"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/acer.12411"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2017.08.430"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1530-0277.2008.00706.x"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1254\/jphs.CR0050020"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2018.09.002"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0920-1211(02)00034-7"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0700-x"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/acer.13917"},{"key":"e_1_2_8_18_1","unstructured":"First M.B. 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