Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States.
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, United States.
Addiction. 2023 Sep;118(9):1710-1725. doi: 10.1111/add.16209. Epub 2023 May 3.
Treatment of depression-related psychological factors related to smoking behavior may improve rates of cessation among adults with major depressive disorder (MDD). This study measured the efficacy and safety of 12 weeks of behavioral activation for smoking cessation (BASC), varenicline and their combination.
DESIGN, SETTING, PARTICIPANTS: This study used a randomized, placebo-controlled, 2 × 2 factorial design comparing BASC versus standard behavioral treatment (ST) and varenicline versus placebo, taking place in research clinics at two urban universities in the United States. Participants comprised 300 hundred adult smokers with current or past MDD.
BASC integrated behavioral activation therapy and ST to increase engagement in rewarding activities by reducing avoidance, withdrawal and inactivity associated with depression. ST was based on the 2008 PHS Clinical Practice Guideline. Both treatments consisted of eight 45-min sessions delivered between weeks 1 and 12. Varenicline and placebo were administered for 12 weeks between weeks 2 and 14.
Primary outcomes were bioverified intent-to-treat (ITT) 7-day point-prevalence abstinence at 27 weeks and adverse events (AEs).
No significant interaction was detected between behavioral treatment and pharmacotherapy at 27 weeks (χ = 0.19, P = 0.67). BASC and ST did not differ (χ = 0.43, P = 0.51). Significant differences in ITT abstinence rates (χ = 4.84, P = 0.03) emerged among pharmacotherapy arms (16.2% for varenicline, 7.5% for placebo), with results favoring varenicline over placebo (rate ratio = 2.16, 95% confidence interval = 1.08, 4.30). All significant differences in AE rates after start of medication were higher for placebo than varenicline.
A randomized trial in smokers with major depressive disorder found that varenicline improved smoking abstinence versus placebo at 27 weeks without elevating rates of adverse events. Behavioral activation for smoking cessation did not outperform standard behavioral treatment, with or without adjunctive varenicline therapy.
治疗与吸烟行为相关的抑郁相关心理因素可能会提高患有重度抑郁症（MDD）的成年人的戒烟率。本研究测量了为期 12 周的行为激活戒烟（BASC）、伐伦克林与安慰剂相比的疗效和安全性。
设计、设置、参与者：这项研究采用了随机、安慰剂对照、2×2 析因设计，比较了 BASC 与标准行为治疗（ST）以及伐伦克林与安慰剂，在美国两所城市大学的研究诊所进行。参与者包括 300 名患有当前或过去 MDD 的成年吸烟者。
BASC 整合了行为激活疗法和 ST，通过减少与抑郁相关的回避、退缩和不活动，增加参与奖励活动的机会。ST 基于 2008 年 PHS 临床实践指南。两种治疗方法均包括 8 次 45 分钟的疗程，从第 1 周到第 12 周进行。伐伦克林和安慰剂在第 2 周到第 14 周期间使用 12 周。
主要结局是生物验证的意向治疗（ITT）27 周时的 7 天点患病率戒断率和不良事件（AE）。
在 27 周时，行为治疗和药物治疗之间没有发现显著的相互作用（χ = 0.19，P = 0.67）。BASC 和 ST 之间没有差异（χ = 0.43，P = 0.51）。在药物治疗组中，ITT 戒断率出现显著差异（χ = 4.84，P = 0.03）（伐伦克林组为 16.2%，安慰剂组为 7.5%），伐伦克林优于安慰剂（率比=2.16，95%置信区间=1.08，4.30）。药物治疗开始后，所有 AE 发生率的显著差异均高于安慰剂组。
在患有重度抑郁症的吸烟者中进行的一项随机试验发现，伐伦克林在 27 周时提高了戒烟率，优于安慰剂，且不增加不良事件的发生率。行为激活戒烟治疗并未优于标准行为治疗，无论是否联合使用伐伦克林治疗。
