Massachusetts General Hospital and Harvard Medical School, Boston.
Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire.
JAMA. 2014 Jan 8;311(2):145-54. doi: 10.1001/jama.2013.285113.
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.
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.
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.
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.
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 < .001). From weeks 12 through 64, 45% (18 of 40) among those in the varenicline group vs 15% (7 of 47) in the placebo group were continuously abstinent (OR, 4.6; 95% CI, 1.5-15.7; P = .004), and from weeks 12 through 76, 30% (12 of 40) in the varenicline group vs 11% (5 of 47) in the placebo group were continuously abstinent (OR, 3.4; 95% CI, 1.02-13.6; P = .03). There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events.
Among smokers with serious mental illness who attained initial abstinence with standard treatment, maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation.
clinicaltrials.gov Identifier: NCT00621777.
据估计，有一半以上的严重精神疾病患者经常吸烟。标准的药物戒烟辅助治疗可以提高短期戒烟率，但大多数戒烟者在停止药物治疗后很快就会复发。
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下是否比标准治疗有更高的长期烟草戒断率。
设计、地点和参与者：这是一项在 10 家社区心理健康中心进行的随机、双盲、安慰剂对照、平行组、预防复发的临床试验。2008 年 3 月至 2012 年 4 月期间，招募了 247 名患有精神分裂症或双相情感障碍的吸烟者，其中 203 名接受了 12 周的开放标签伐伦克林和认知行为治疗，87 名符合戒烟标准进入预防复发干预。
在开放治疗的第 12 周有 2 周或以上持续戒烟的参与者被随机分配接受认知行为治疗和双盲伐伦克林（1 毫克，每天 2 片）或安慰剂，从第 12 周到第 52 周。参与者随后停止研究治疗，并随访至第 76 周。
第 52 周（预防复发阶段结束）的 7 天持续戒烟率，通过呼出的一氧化碳来证实。次要结果是根据生物化学验证的戒烟和自我报告的吸烟行为，在第 12 周到第 64 周和第 12 周到第 76 周的连续戒烟率。
61 名参与者完成了预防复发阶段；26 名参与者（7 名伐伦克林，19 名安慰剂）退出了研究，被认为是复发，其中 18 名在退出前就已经复发。在第 52 周时，伐伦克林组的点患病率为 60%（40 人中 24 人），安慰剂组为 19%（47 人中 9 人）（比值比[OR]，6.2；95%置信区间[CI]，2.2-19.2；P < 0.001）。从第 12 周到第 64 周，伐伦克林组中有 45%（40 人中 18 人）的人持续戒烟，安慰剂组中有 15%（47 人中 7 人）（OR，4.6；95% CI，1.5-15.7；P = 0.004），从第 12 周到第 76 周，伐伦克林组中有 30%（40 人中 12 人）的人持续戒烟，安慰剂组中有 11%（47 人中 5 人）（OR，3.4；95% CI，1.02-13.6；P = 0.03）。在精神病症状评分或精神病不良事件方面，没有显著的治疗效果。
在接受标准治疗达到初始戒烟的严重精神疾病吸烟者中，与单独接受认知行为治疗相比，伐伦克林和认知行为治疗的维持药物治疗在治疗 1 年后和治疗停止后 6 个月时提高了长期烟草戒断率。
clinicaltrials.gov 标识符：NCT00621777。
