Comprehensive Recovery Services, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, 3811 O'Hara St, Pittsburgh, PA 15213-2593
J Clin Psychiatry. 2014 Jul;75(7):765-72. doi: 10.4088/JCP.13m08756.
Virtually no clinical trials for smoking cessation have been undertaken in bipolar disorder. Varenicline has shown efficacy for smoking cessation, but warnings about neuropsychiatric adverse events have been issued. We assessed the efficacy and safety of varenicline in euthymic bipolar subjects motivated to quit smoking.
Clinically stable adult patients with DSM-IV bipolar disorder (n = 60) who smoked ≥ 10 cigarettes per day were randomized to a 3-month, double-blind, placebo-controlled varenicline trial and a 3-month follow-up. Study enrollment was completed from February 2010 through March 2013. Varenicline was dosed using standard titration, and smoking cessation counseling was provided to all patients. The primary outcome was defined as a 7-day point prevalence of self-reported no smoking verified by expired carbon monoxide level < 10 ppm at 12 weeks. Psychopathology and side-effects were assessed at each visit.
At 3 months (end of treatment), significantly more subjects quit smoking with varenicline (n/n = 15/31, 48.4%) than with placebo (n/n = 3/29, 10.3%) (OR = 8.1; 95% CI, 2.03-32.5; P < .002). At 6 months, 6 of 31 varenicline-treated subjects (19.4%) remained abstinent compared to 2 of 29 (6.90%) assigned to placebo (OR = 3.2; 95% CI, 0.60-17.6; P = .17). Psychopathology scores remained stable. Ten serious adverse events occurred (n = 6, varenicline; n = 4, placebo). Abnormal dreams occurred significantly more often in varenicline-treated subjects (n/n = 18/31, 61.3%) than in those receiving placebo (n/n = 9/29, 31%; Fisher exact test, P = .04). Eight varenicline-treated and 5 placebo-assigned subjects expressed fleeting suicidal ideation, a nonsignificant difference.
Varenicline shows efficacy for initiating smoking cessation in bipolar patients, but medication trials of longer duration are warranted for maintaining abstinence. Vigilance for neuropsychiatric adverse events is prudent when initiating varenicline for smoking cessation in this patient population.
ClinicalTrials.gov identifier: NCT01010204.
几乎没有针对双相情感障碍患者的戒烟临床试验。维拉唑酮已被证明对戒烟有效，但已发出关于神经精神不良事件的警告。我们评估了在有戒烟意愿的双相情感稳定期患者中使用维拉唑酮的疗效和安全性。
符合 DSM-IV 双相情感障碍诊断标准的成年患者（n=60），每日吸烟≥10 支，被随机分为 3 个月双盲、安慰剂对照的维拉唑酮试验和 3 个月随访期。研究招募于 2010 年 2 月至 2013 年 3 月完成。根据标准滴定法调整维拉唑酮剂量，并向所有患者提供戒烟咨询。主要结局定义为 12 周时自我报告的 7 天点吸烟率，通过呼出一氧化碳水平<10ppm 验证。在每次就诊时评估精神病理学和副作用。
在 3 个月（治疗结束时），维拉唑酮组戒烟的患者明显多于安慰剂组（n/n=15/31，48.4%）（OR=8.1；95%CI，2.03-32.5；P<.002）。在 6 个月时，维拉唑酮治疗组的 6 名（19.4%）患者保持戒烟，而安慰剂组为 2 名（6.90%）（OR=3.2；95%CI，0.60-17.6；P=.17）。精神病理学评分保持稳定。共发生 10 例严重不良事件（n=6，维拉唑酮；n=4，安慰剂）。维拉唑酮治疗组异常梦境的发生率明显高于安慰剂组（n/n=18/31，61.3%）（n/n=9/29，31%；Fisher 精确检验，P=.04）。维拉唑酮治疗组有 8 名和安慰剂组有 5 名患者短暂出现自杀意念，无显著差异。
维拉唑酮对双相情感障碍患者戒烟有效，但需要更长时间的药物试验来维持戒烟。在为该患者人群启动维拉唑酮戒烟治疗时，应谨慎监测神经精神不良事件。
ClinicalTrials.gov 标识符：NCT01010204。
