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The aim of the current study was to determine whether treatment with CERC\u2010501, an orally available, potent, and selective kappa opioid receptor antagonist, could alleviate nicotine withdrawal and craving and mitigate mood alterations associated with nicotine withdrawal in humans. Healthy, adult cigarette smokers were enrolled into this randomized, multisite, double\u2010blind, placebo\u2010controlled, crossover study. Participants completed two 8\u2010day treatment phases during which they received either CERC\u2010501 (15 mg, p.o., once daily) or placebo. On the seventh day of each dosing phase, participants were admitted as inpatients for an 18\u2010hour cigarette abstinence period followed by experimental testing. The primary outcome measures were (a) performance on the McKee Smoking Lapse test (ie, latency to smoke in exchange for money) and (b) number of cigarettes self\u2010administered during a 60\u2010minute ad lib smoking period. Other outcomes included measures of craving, mood, anxiety, nicotine withdrawal, and subjective effects of cigarette smoking. A total of 71 participants who smoked an average of approximately 23 cigarettes per day were enrolled, and 56 subjects completed the study. CERC\u2010501 was well tolerated, but it did not significantly alter the latency to start smoking (CERC\u2010501: 16.5 min vs placebo: 17.7 min) or the number of cigarettes smoked (CERC\u2010501: 3.3 cigarettes vs placebo: 3.1 cigarettes). Compared with placebo, CERC\u2010501 also did not affect cigarette craving, mood, anxiety, nicotine withdrawal, or subjective effects of smoking. These findings do not support a role for CERC\u2010501 in the treatment of nicotine use disorder.<\/jats:p>","DOI":"10.1111\/adb.12799","type":"journal-article","created":{"date-parts":[[2019,6,26]],"date-time":"2019-06-26T07:44:42Z","timestamp":1561535082000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["A randomized, double\u2010blind, placebo\u2010controlled study of the kappa opioid receptor antagonist, CERC\u2010501, in a human laboratory model of smoking behavior"],"prefix":"10.1111","volume":"25","author":[{"given":"Jermaine D.","family":"Jones","sequence":"first","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons  New York City New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shanna","family":"Babalonis","sequence":"additional","affiliation":[{"name":"Department of Behavioral Science, Center on Drug and Alcohol Research University of Kentucky  Lexington Kentucky USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald","family":"Marcus","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals  Rockville Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bradley","family":"Vince","sequence":"additional","affiliation":[{"name":"Vince and Associates  Overland Park Kansas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debra","family":"Kelsh","sequence":"additional","affiliation":[{"name":"Vince and Associates  Overland Park Kansas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle R.","family":"Lofwall","sequence":"additional","affiliation":[{"name":"Department of Behavioral Science, Center on Drug and Alcohol Research University of Kentucky  Lexington Kentucky USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Fraser","sequence":"additional","affiliation":[{"name":"Cerecor Inc  Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Blake","family":"Paterson","sequence":"additional","affiliation":[{"name":"NRZ Consulting  Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suky","family":"Martinez","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons  New York City New York USA"},{"name":"Translational Research Training Program in Addiction City College of New York  New York City New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana M.","family":"Martinez","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons  New York City New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward V.","family":"Nunes","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons  New York City New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon L.","family":"Walsh","sequence":"additional","affiliation":[{"name":"Department of Behavioral Science, Center on Drug and Alcohol Research University of Kentucky  Lexington Kentucky USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra D.","family":"Comer","sequence":"additional","affiliation":[{"name":"Division on Substance Use Disorders New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons  New York City New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,6,26]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6444a2"},{"key":"e_1_2_9_3_1","unstructured":"United Nations Office on Drugs and Crime World Drug Report.(United Nations publication Sales No. E.16. 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