{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T19:36:13Z","timestamp":1791920173924,"version":"4.3.4"},"reference-count":27,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,11,13]],"date-time":"2019-11-13T00:00:00Z","timestamp":1573603200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","award":["UL1 TR001085"],"award-info":[{"award-number":["UL1 TR001085"]}],"id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl J Eating Disorders"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Open trials suggest phentermine\/topiramate ER (PHEN\/TPM\u2010ER), food and drug administration (FDA) approved for obesity, has utility for binge eating. With no randomized controlled trials (RCTs) yet performed, this trial aimed to evaluate PHEN\/TPM\u2010ERs efficacy and safety in a crossover RCT for patients with binge\u2010eating disorder (BED) or bulimia nervosa (BN).<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>Participants were randomized to 12\u2010weeks PHEN\/TPM\u2010ER (3.75\u2009mg\/23\u2009mg\u201315\u2009mg\/92\u2009mg) or placebo followed by 2\u2010weeks drug washout, then 12\u2010week crossover. Demographics, vitals, eating disorder behaviors, mood, and side effects were measured. Primary outcome was objective binge\u2010eating (OBE) days\/4\u2010weeks; secondary outcomes included binge abstinence. Mixed\u2010effect models estimated treatment effects, with fixed effects adjusting for treatment, study period, and diagnosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The 22 adults (BED = 18, BN = 4) were female (96%), Caucasian (55%), aged 42.9 (<jats:italic>SD<\/jats:italic> = 10.1) years with body mass index = 31.1 (<jats:italic>SD<\/jats:italic> = 6.2) kg\/m<jats:sup>2<\/jats:sup>. Baseline OBE days\/4\u2010weeks decreased from 16.2 (<jats:italic>SD<\/jats:italic> = 7.8) to 4.2 (<jats:italic>SD<\/jats:italic> = 8.4) after PHEN\/TPM\u2010ER versus 13.2 (<jats:italic>SD<\/jats:italic> = 9.1) after placebo (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.0001), with abstinence rates = 63.6% on PHEN\/TPM\u2010ER versus 9.1% on placebo (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.0001). Weight changes = \u22125.8 kg on PHEN\/ TPM\u2010ER versus +0.4 kg on placebo. Drop\u2010out = 2 (9%) on PHEN\/TPM\u2010ER and 2 (9%) on placebo, with few side effects. Vital sign changes with PHEN\/TPM\u2010ER were minimal and similar to placebo. Responses were not significantly different for BED versus BN.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This first RCT to evaluate the efficacy and safety of PHEN\/TPM\u2010ER for BED\/BN found this drug combination significantly more effective at reducing binge eating than placebo and well tolerated. However, with only four participants with BN, findings regarding the safety of PHEN\/TPM\u2010ER in patients with BN must be taken with caution.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link> identifier NCT02553824 registered on 9\/17\/2015. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02553824\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02553824<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1002\/eat.23192","type":"journal-article","created":{"date-parts":[[2019,11,13]],"date-time":"2019-11-13T11:12:29Z","timestamp":1573643549000},"page":"266-277","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":63,"title":["A randomized, placebo\u2010controlled crossover trial of phentermine\u2010topiramate ER in patients with binge\u2010eating disorder and bulimia nervosa"],"prefix":"10.1002","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9874-2277","authenticated-orcid":false,"given":"Debra L.","family":"Safer","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine  Stanford California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Adler","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine  Stanford California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shebani","family":"Sethi","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine  Stanford California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason P.","family":"Bentley","sequence":"additional","affiliation":[{"name":"Quantitative Sciences Unit Stanford University School of Medicine  Stanford California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Toyama","sequence":"additional","affiliation":[{"name":"Department of Psychology Palo Alto University  Palo Alto California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Pajarito","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine  Stanford California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Najarian","sequence":"additional","affiliation":[{"name":"Najarian Center for Obesity  Los Osos California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,11,13]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.genhosppsych.2008.02.002"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/oby.20584"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03327"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1210\/en.2012-1272"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/eat.20422"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/1098-108X(199412)16:4<363::AID-EAT2260160405>3.0.CO;2-#"},{"key":"e_1_2_9_8_1","first-page":"317","volume-title":"Binge eating: Nature, assessment, and treatment","author":"Fairburn C. 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