Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

行为激活和伐尼克兰对抑郁吸烟者戒烟的作用

• 批准号: 8930935
• 负责人: Brian L Hitsman
• 金额: $ 64.12万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-22 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8930935
• 关键词: Abstinence; Address; Adult; Adverse event; Affective; Anhedonia; Attention; Behavioral; Behavioral trial; Carbon Monoxide; Cardiovascular system; Cigarette; Cognition; Cognitive; Cognitive Therapy; Communities; Data; Depressed mood; Double-Blind Method; Enrollment; Evaluation; Event; Gender; Goals; Health; Hour; Impaired cognition; Individual; Link; Maintenance; Major Depressive Disorder; Mediating; Mediation; Mediator of activation protein; Memory; Mental Depression; Mental disorders; Meta-Analysis; Modeling; Moods; Negative Reinforcements; Outcome; Participant; Patients; Pattern; Persons; Placebo Control; Placebos; Population; Positive Reinforcements; Prevalence; Process; Psychological Factors; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Rewards; Safety; Sampling; Severities; Smoke; Smoker; Smoking; Smoking Behavior; Stratification; Subgroup; Telephone; Testing; Time; Tobacco; Tobacco Dependence; Treatment Efficacy; Underserved Population; Withdrawal; Withholding Treatment; Work; arm; base; burden of illness; cigarette smoking; clinical practice; clinical research site; cognitive function; craving; depressive symptoms; design; experience; hedonic; improved; innovation; insight; multi-component intervention; primary outcome; psychologic; randomized placebo controlled trial; skill acquisition; skills; smoking cessation; treatment effect; treatment strategy; varenicline

DESCRIPTION (provided by applicant): This project answers many prominent but largely unanswered calls over the last decade to address tobacco dependence in persons with mental health disorders, especially major depressive disorder (MDD). Upwards of 43% of persons with MDD are daily smokers who are more likely to smoke heavily, show greater tobacco dependence, suffer more severe withdrawal, and experience lower quit rates than smokers without MDD. Very little is known about treatment strategies that might optimize smoking cessation for smokers with MDD because almost all randomized clinical trials have excluded these smokers. We conducted a meta-analysis of 42 randomized clinical trials (RCTs) comprising nearly 3000 smokers with past MDD given that these data were routinely collected and offer insight into potential treatment approaches for patients with current or recent MDD. Results showed that CBT mood management (CBT MM) and varenicline individually had the strongest associations with short-term abstinence. Varenicline also had the strongest association with long-term abstinence. Behavioral activation (BA) is simpler to administer and easier for patients to understand than CBT MM and therefore may enhance skill acquisition/retainment and long-term abstinence. The goal of BA is to increase engagement in rewarding activities, a problem for smokers with MDD who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of avoidance, withdrawal, and inactivity. Combination treatment with BA and varenicline has great potential to improve long- term abstinence rates for smokers with current or recent MDD because it addresses the unique psychological factors that may maintain their tobacco dependence. This proposed double-blind, placebo-controlled, randomized trial will evaluate the efficacy of BA plus varenicline for treating tobacco dependence in smokers with current or recent (past year) MDD. Six hundred and thirty daily (e5 cigarettes/day) smokers with at least moderate depressive symptoms will be randomized to receive 12 weeks of one of four treatments: 1) Standard behavioral cessation treatment (ST) + placebo; 2) BA integrated with ST (BA) + placebo; 3) ST + varenicline; or 4) BA + varenicline. Both BA and ST will be administered in eight 1-hour sessions, occurring weekly for the first four weeks and biweekly for the final eight weeks. Randomization will be stratified on clinical site (Northwestern, PENN), gender, and severity of depressive symptoms (moderate vs. severe). The primary outcomes will be carbon monoxide (CO) verified 7-day point prevalence abstinence at 24-weeks post-quit. Additional aims include assessing adverse event rates between varenicline and placebo arms, and testing for mediation of treatment effects by anhedonia, cognitive function (attention and memory), cigarette reward value, and craving and withdrawal. This will be the first adequately powered trial of BA for smoking cessation in this population; the first RCT to evaluate varenicline among a community sample of smokers with MDD; and the first RCT to assess the main and combined effects of these two treatments.

描述（由申请人提供）：该项目回应了过去十年中许多突出但基本上没有得到回应的呼吁，以解决精神健康障碍患者，特别是重度抑郁症（MDD）患者的烟草依赖问题。超过 43% 的重度抑郁症患者是日常吸烟者，与没有重度抑郁症的吸烟者相比，他们更有可能大量吸烟、表现出更大的烟草依赖性、更严重的戒断症状，​​并且戒烟率更低。对于可能优化重度抑郁症吸烟者戒烟的治疗策略知之甚少，因为几乎所有随机临床试验都排除了这些吸烟者。我们对 42 项随机临床试验 (RCT) 进行了荟萃分析，其中包括近 3000 名既往患有 MDD 的吸烟者，因为这些数据是常规收集的，并为当前或近期患有 MDD 的患者提供了潜在治疗方法的见解。结果显示，CBT 情绪管理 (CBT MM) 和伐尼克兰与短期戒断的相关性最强。伐尼克兰与长期禁欲的关联也最强。行为激活 (BA) 比 CBT MM 更容易管理，也更容易让患者理解，因此可以增强技能获取/保留和长期戒断。 BA 的目标是通过减少回避、戒断和不活动的模式，增加对奖励活动的参与，这是患有重度抑郁症 (MDD) 的吸烟者面临的一个问题，他们发现吸烟特别有益，并且比许多其他传统奖励活动更喜欢吸烟。 BA 和伐尼克兰的联合治疗对于提高当前或近期患有 MDD 的吸烟者的长期戒烟率具有巨大潜力，因为它解决了可能维持其烟草依赖的独特心理因素。这项拟议的双盲、安慰剂对照、随机试验将评估 BA 加伐尼克兰治疗当前或近期（去年）患有 MDD 的吸烟者的烟草依赖的疗效。 630 名至少患有中度抑郁症状的每天（e5 支香烟/天）吸烟者将被随机接受为期 12 周的四种治疗方法之一： 1) 标准行为戒烟治疗 (ST) + 安慰剂； 2）BA结合ST（BA）+安慰剂； 3) ST+伐尼克兰；或4) BA + 伐尼克兰。 BA 和 ST 都将分为八次，每次 1 小时，前 4 周每周一次，后 8 周每两周一次。随机分组将根据临床地点（西北大学、PENN）、性别和抑郁症状的严重程度（中度与重度）进行分层。主要结果是戒烟后 24 周时一氧化碳 (CO) 验证的 7 天点流行率戒烟情况。其他目标包括评估伐尼克兰组和安慰剂组之间的不良事件发生率，并测试快感缺乏、认知功能（注意力和记忆）、香烟奖励值以及渴望和戒断对治疗效果的调节。这将是 BA 在该人群中进行的首次戒烟试验。第一个在患有 MDD 的吸烟者社区样本中评估伐尼克兰的随机对照试验；以及第一个评估这两种治疗的主要效果和综合效果的随机对照试验。