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Despite recent efforts, the identification of a non\u2010abstinence alternative as a clinically meaningful end\u2010point for drug use trials has been elusive.<\/jats:p><\/jats:sec><jats:sec><jats:title>Argument and analysis<\/jats:title><jats:p>The current standard for establishing a clinically meaningful outcome in SUD trials is to demonstrate that a reduction in drug use is associated with improvement in long\u2010term functioning, but data indicate relatively weak associations between drug use and various psychosocial problem domains. This may be because assessments used most commonly to measure an individual's functioning do not specify whether aspects of functioning are a direct consequence of drug use. The acceptance of a non\u2010abstinence\u2010based end\u2010point for alcohol use disorder trials was supported in part through associations with reductions in alcohol\u2010related consequences, although measures designed to assess the direct consequences of drug use are rarely included in drug treatment efficacy trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The field of substance use disorders should include measures of negative psychosocial and health consequences of drug use, as opposed to overall functioning, in the effort to establish meaningful non\u2010abstinence\u2010based end\u2010points.<\/jats:p><\/jats:sec>","DOI":"10.1111\/add.14289","type":"journal-article","created":{"date-parts":[[2018,6,14]],"date-time":"2018-06-14T06:06:10Z","timestamp":1528956370000},"page":"9-15","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":66,"title":["What defines a clinically meaningful outcome in the treatment of substance use disorders: reductions in direct consequences of drug use or improvement in overall functioning?"],"prefix":"10.1111","volume":"114","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1175-7979","authenticated-orcid":false,"given":"Brian D.","family":"Kiluk","sequence":"first","affiliation":[{"name":"Department of Psychiatry Yale School of Medicine  New Haven CT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garrett M.","family":"Fitzmaurice","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Harvard Medical School  Boston MA USA"},{"name":"Laboratory for Psychiatric Biostatistics McLean Hospital  Belmont MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric C.","family":"Strain","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences Johns Hopkins University School of Medicine  Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger D.","family":"Weiss","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Harvard Medical School  Boston MA USA"},{"name":"Division of Alcohol and Drug Abuse McLean Hospital  Belmont MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,6,27]]},"reference":[{"key":"e_1_2_5_2_1","unstructured":"European Medicines Agency (EMA).Guideline on the Development of Medicinal Products for the Treatment of Alcohol Dependence. 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