{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T08:37:00Z","timestamp":1790066220259,"version":"4.0.1"},"reference-count":51,"publisher":"Oxford University Press (OUP)","issue":"5","funder":[{"name":"USAMRMC Military Operational Medicine Joint Program Committee 5"},{"DOI":"10.13039\/100000090","name":"Congressionally Directed Medical Research Programs","doi-asserted-by":"publisher","award":["W81XWH-14-1-0025"],"award-info":[{"award-number":["W81XWH-14-1-0025"]}],"id":[{"id":"10.13039\/100000090","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,7,21]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>We conducted a proof-of-concept randomized controlled trial of the mu-opioid receptor antagonist, naltrexone, augmented with the alpha-1 adrenergic receptor antagonist, prazosin, for alcohol use disorder in veterans. We sought a signal that the naltrexone plus prazosin combination regimen would be superior to naltrexone alone.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Thirty-one actively drinking veterans with alcohol use disorder were randomized 1:1:1:1 to naltrexone plus prazosin (NAL-PRAZ [n\u2009=\u20098]), naltrexone plus placebo (NAL-PLAC [n\u2009=\u20097]), prazosin plus placebo (PRAZ-PLAC [n\u2009=\u20097]), or placebo plus placebo (PLAC-PLAC [n\u2009=\u20099]) for 6\u00a0weeks. Prazosin was titrated over 2\u00a0weeks to a target dose of 4\u00a0mg QAM, 4\u00a0mg QPM, and 8\u00a0mg QHS. Naltrexone was administered at 50\u00a0mg QD. Primary outcomes were the Penn Alcohol Craving Scale (PACS), % drinking days (PDD), and % heavy drinking days (PHDD).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the NAL-PRAZ condition, % reductions from baseline for all three primary outcome measures exceeded 50% and were at least twice as large as % reductions in the NAL-PLAC condition (PACS: 57% vs. 26%; PDD: 51% vs. 22%; PHDD: 69% vs. 15%) and in the other two comparator conditions. Standardized effect sizes between NAL-PRAZ and NAL-PLAC for each primary outcome measure were\u2009&amp;gt;0.8. All but one participant assigned to the two prazosin containing conditions achieved the target prazosin dose of 16\u00a0mg\/day and maintained that dose for the duration of the trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>These results suggest that prazosin augmentation of naltrexone enhances naltrexone benefit for alcohol use disorder. These results strengthen rationale for an adequately powered definitive randomized controlled trial.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/alcalc\/agae062","type":"journal-article","created":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T08:04:20Z","timestamp":1726301060000},"source":"Crossref","is-referenced-by-count":6,"title":["Naltrexone augmented with prazosin for alcohol use disorder: results from a randomized controlled proof-of-concept trial"],"prefix":"10.1093","volume":"59","author":[{"given":"Tracy L","family":"Simpson","sequence":"first","affiliation":[{"name":"Center of Excellence in Substance Addiction Treatment and Education (CESATE), Veterans Affairs (VA) Puget Sound Health Care System , 1660 So. 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Columbian Way, Seattle, WA 98108"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine R","family":"Peskind","sequence":"additional","affiliation":[{"name":"Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine , 1959 Pacific Ave, Seattle, WA 98195"},{"name":"VA Northwest Mental Illness Research , Education, and Clinical Center (MIRECC), , 1660 So. Columbian Way, Seattle, WA 98108"},{"name":"VA Puget Sound Health Care System , Education, and Clinical Center (MIRECC), , 1660 So. Columbian Way, Seattle, WA 98108"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J","family":"Saxon","sequence":"additional","affiliation":[{"name":"Center of Excellence in Substance Addiction Treatment and Education (CESATE), Veterans Affairs (VA) Puget Sound Health Care System , 1660 So. Columbian Way, Seattle, WA 98108"},{"name":"Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine , 1959 Pacific Ave, Seattle, WA 98195"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray A","family":"Raskind","sequence":"additional","affiliation":[{"name":"Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine , 1959 Pacific Ave, Seattle, WA 98195"},{"name":"VA Northwest Mental Illness Research , Education, and Clinical Center (MIRECC), , 1660 So. Columbian Way, Seattle, WA 98108"},{"name":"VA Puget Sound Health Care System , Education, and Clinical Center (MIRECC), , 1660 So. 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