Maintenance Treatment With Varenicline for Smoking Cessation in Patients With Schizophrenia and Bipolar Disorder A Randomized Clinical Trial
Maintenance Treatment With Varenicline for Smoking Cessation in Patients With Schizophrenia and Bipolar Disorder A Randomized Clinical Trial
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DOI：
10.1001/jama.2013.285113
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发表时间：
2014-01-08
影响因子：
120.7
通讯作者：
Schoenfeld, David A.
中科院分区：
文献类型：
--
作者：
Evins, A. Eden;Cather, Corinne;Schoenfeld, David A.
重要性据估计，超过一半的严重精神疾病患者经常吸烟。标准的戒烟疗程有助于改善短期戒烟，但大多数达到戒烟的人在停止药物治疗后迅速复发。目的：确定诊断为精神分裂症和双相情感障碍的吸烟者在维持药物治疗后是否比标准治疗有更高的长期戒烟率。在10个社区精神卫生中心进行的预防复发临床试验。在2008年3月至2012年4月招募的247名患有精神分裂症或双相情感障碍的吸烟者中，203人接受了12周的开放式培训-干预在开放治疗的第12周连续戒断2周或更长时间的参与者被随机分配接受认知行为治疗，和双盲伐尼克兰（1毫克，每天2次）或安慰剂，从第12周至第52周。然后，参与者停止研究治疗，并随访至第76周。主要结果和指标：在研究第52周，即预防复发阶段结束时，通过呼出的一氧化碳证实的7天连续戒烟率。次要结果是基于生物化学证实的戒烟和基于自我报告的吸烟行为的第12周至第76周的持续戒烟率。结果：61名参与者完成了复发预防阶段; 26名停止参与（7名伐尼克兰，19名安慰剂），并被认为在分析中复发;其中18名在脱落前复发。在第52周，伐尼克兰组的点患病率戒断率为60%（40例中有24例），安慰剂组为19%（47例中有9例）（比值比[OR]，6.2; 95%CI，2.2-19.2; P
IMPORTANCE It is estimated that more than half of those with serious mental illness smoke tobacco regularly. Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence, but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy.OBJECTIVE To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment.DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind, placebo-controlled, parallel-group, relapse-prevention clinical trial conducted in 10 community mental-health centers. Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012, 203 received 12-weeks' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention.INTERVENTIONS Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline (1 mg, 2 per day) or placebo from weeks 12 to 52. Participants then discontinued study treatment and were followed up to week 76. MAIN OUTCOMES AND MEASURES Seven-day rate of continuous abstinence at study week 52, the end of the relapse-prevention phase, confirmed by exhaled carbon monoxide. Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76, based on self-reported smoking behavior. RESULTS Sixty-one participants completed the relapse-prevention phase; 26 discontinued participation (7 varenicline, 19 placebo) and were considered to have relapsed for the analyses; 18 of these had relapsed prior to dropout. At week 52, point-prevalence abstinence rates were 60% in the varenicline group (24 of 40) vs 19% (9 of 47) in the placebo group (odds ratio [OR], 6.2; 95% CI, 2.2-19.2; P