{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T14:58:10Z","timestamp":1781017090395,"version":"3.54.1"},"reference-count":69,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2016,4,15]],"date-time":"2016-04-15T00:00:00Z","timestamp":1460678400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Addiction"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>We compared the risk of mental health episodes requiring hospitalization (primary aim) or out\u2010patient clinic visits (secondary aim) associated with varenicline versus the nicotine patch (NP) in an era prior to psychiatric boxed warnings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Retrospective cohort.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Department of Veterans Affairs (VA), USA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>VA patients with or without psychiatric comorbidities and a new prescription for varenicline (15\u00a0255) were propensity score\u2010matched (1\u00a0:\u00a02) to new users of NP (123\u00a0054) between 1\u00a0May 2006 and 30\u00a0September 2007, resulting in 11\u00a0774 and 23\u00a0548 patients in the varenicline and NP groups, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Measurements<\/jats:title><jats:p>The primary outcomes were hospitalizations with a primary discharge diagnosis of a range of mental health disorders: depression, schizophrenia, bipolar disorder, suicide attempt, post\u2010traumatic stress disorder, other psychosis and drug\u2010induced mental disorders. Secondary outcomes were out\u2010patient clinic visits with a primary diagnosis of the above list of mental health disorders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Background characteristics of the treatment groups were similar after matching. There was no statistically significant difference in risk of hospitalization for any of the studied mental health disorders with varenicline compared with NP. Among secondary outcomes there was an increased risk of out\u2010patient clinic visits for schizophrenia among patients who received varenicline [hazard ratio (HR)\u00a0=\u00a01.27; 95% confidence interval (CI)\u00a0=\u00a01.07, 1.51], this increase being evident only in those with a pre\u2010existing mental health disorder.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In US VA patients studied prior to the boxed warning being implemented, use of varenicline for smoking cessation was not associated with a detectable increase compared with nicotine patches in hospitalization for any mental health outcomes. There was an increased rate of out\u2010patient attendances with a primary diagnosis of schizophrenia amounting to five per 100 person years of treatment. This increase was found only in patients with a pre\u2010existing mental health disorder.<\/jats:p><\/jats:sec>","DOI":"10.1111\/add.13329","type":"journal-article","created":{"date-parts":[[2016,1,30]],"date-time":"2016-01-30T14:03:55Z","timestamp":1454162635000},"page":"1283-1292","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["A comparison of neuropsychiatric adverse events during early treatment with varenicline or a nicotine patch"],"prefix":"10.1111","volume":"111","author":[{"given":"Francesca E.","family":"Cunningham","sequence":"first","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwan","family":"Hur","sequence":"additional","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane","family":"Dong","sequence":"additional","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald R.","family":"Miller","sequence":"additional","affiliation":[{"name":"Boston University School of Public Health  Boston MA USA"},{"name":"Center for Health Quality Outcomes and Economic Research  Bedford MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongping","family":"Zhang","sequence":"additional","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangming","family":"Wei","sequence":"additional","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madeline","family":"McCarren","sequence":"additional","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew D.","family":"Mosholder","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Graham","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherrie L.","family":"Aspinall","sequence":"additional","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"},{"name":"VA Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System  Pittsburgh PA USA"},{"name":"University of Pittsburgh, School of Pharmacy  Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chester B.","family":"Good","sequence":"additional","affiliation":[{"name":"VA Center for Medication Safety  Hines IL USA"},{"name":"VA Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System  Pittsburgh PA USA"},{"name":"University of Pittsburgh, School of Medicine  Pittsburgh PA USA"},{"name":"University of Pittsburgh, School of Pharmacy  Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,4,15]]},"reference":[{"key":"e_1_2_5_2_1","first-page":"277","volume-title":"Approval package for: application number NDA 21\u2010928 [Clinical safety review: varenicline tartrate]","author":"Josefberg H.","year":"2006"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.6.614"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.15.1561"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.15.1571"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.296.1.64"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.296.1.47"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2007.06.012"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.296.1.56"},{"key":"e_1_2_5_10_1","unstructured":"FDA News Release11\u00a0May2006.FDA approves novel medication for smoking cessation. 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