{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T13:55:56Z","timestamp":1790949356947,"version":"4.1.0"},"reference-count":38,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2016,12,28]],"date-time":"2016-12-28T00:00:00Z","timestamp":1482883200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Alcoholism Clin &amp;amp; Exp Res"],"published-print":{"date-parts":[[2017,1]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Alcohol and nicotine dependence frequently co\u2010occur, and quitting smoking might enhance long\u2010term alcohol abstinence. Topiramate appears to help non\u2010alcohol\u2010dependent individuals quit smoking, and our pilot work suggested efficacy only in men. It also prevents relapse to alcohol in recently detoxified alcoholics. We evaluated topiramate in abstinent alcohol\u2010dependent men to assess whether this medication (i) promotes smoking cessation and (ii) prevents alcohol and other drug relapse in the context of smoking cessation treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>One hundred and twenty\u2010nine alcohol\u2010abstinent (mean ~6\u00a0months) alcohol\u2010dependent male smokers (80% with other substance use disorders) participated in this 12\u2010week randomized, double blind, parallel group comparison of topiramate (up to 200\u00a0mg\/d) and placebo with a 24\u2010week nontreatment follow\u2010up period. The study was carried out sequentially at 2 academic centers in the Midwest and Southern California between March 23, 2009 and November 20, 2014. All participants received manual\u2010guided smoking cessation counseling combined with medication\u2010focused compliance enhancement therapy. Randomization was block designed by the research pharmacist in a 1:1 ratio. Participants, investigators, and research personnel were masked to treatment assignment. The primary smoking end point was biochemically confirmed 4\u2010week continuous abstinence from smoking during weeks 9 to 12, while the secondary end point was relapse to any drinking or drug use during the entire 36\u2010week evaluation period. Logistic regression was used to determine the effects of topiramate on quitting smoking and alcohol relapse, controlling for relevant covariates. The trial is registered at ClinicalTrials.gov (number <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00802412) and is now closed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Only a small proportion (7.9%) of topiramate\u2010treated participants were able to quit smoking, and this cessation rate was similar to placebo (10.6%; odds ratio\u00a0=\u00a01.60; 95% confidence interval 0.4, 6.5; <jats:italic>p<\/jats:italic>\u00a0=\u00a00.51). Roughly 30% of the sample had a documented relapse to drinking or drug use during the study, and these rates were similar in the topiramate (20\/63; 31.8%) and placebo groups (18\/66; 27.3%; <jats:italic>p<\/jats:italic>\u00a0=\u00a00.58). Results of a longitudinal logistic regression model examining time to any alcohol relapse revealed no medication effect.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Topiramate at a daily dosage of up to 200\u00a0mg per day, combined with smoking cessation and medication adherence counseling, had no effects on smoking cessation or the prevention of alcohol or drug relapse in male smokers who were in early or sustained full remission from alcohol and motivated to make a quit attempt. Alternative approaches for treating this high\u2010risk, dually dependent population are needed.<\/jats:p><\/jats:sec>","DOI":"10.1111\/acer.13279","type":"journal-article","created":{"date-parts":[[2016,12,28]],"date-time":"2016-12-28T12:23:14Z","timestamp":1482927794000},"page":"197-206","source":"Crossref","is-referenced-by-count":26,"title":["A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol\u2010Dependent Men"],"prefix":"10.1111","volume":"41","author":[{"given":"Robert M.","family":"Anthenelli","sequence":"first","affiliation":[{"name":"Pacific Treatment and Research Center VA San Diego Healthcare System San Diego California"},{"name":"Department of Psychiatry Health Sciences University of California, San Diego La Jolla California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaimee L.","family":"Heffner","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Research 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