An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

尼古丁依赖维持治疗的有效性试验

• 批准号: 7651790
• 负责人: Robert A Schnoll
• 金额: $ 66.58万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-15 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7651790
• 关键词: Abstinence; Acute; Address; Adoption; Adult; Adverse effects; Affect; Aftercare; Asthma; Behavioral; Chronic; Chronic Disease; Clinical Trials; Computer Simulation; Counseling; Data; Databases; Diabetes Mellitus; Dose; Effectiveness; Eligibility Determination; Europe; Evaluation; Event; Exclusion Criteria; Exhibits; Failure; Future; Gender; Goals; Guidelines; Healthy People 2010; Heroin Dependence; Hypertension; Individual; Individual Differences; Life; Maintenance; Maintenance Therapy; Masks; Mediator of activation protein; Medical; Metabolism; Methods; Modeling; Nature; Nicotine; Nicotine Dependence; Opiate Addiction; Outcome; Participant; Pattern; Placebo Control; Placebos; Prevalence; Publishing; Race; Randomized; Randomized Controlled Clinical Trials; Recommendation; Recovery; Relapse; Research; Research Design; Rest; Risk; Safety; Serious Adverse Event; Smoke; Smoker; Smoking; Therapeutic; Third-Party Payer; Tobacco Dependence; Tobacco Use Cessation; Tobacco use; Treatment Protocols; Treatment outcome; United States Dept. of Health and Human Services; United States Public Health Service; Upper arm; Withdrawal; Withdrawal Symptom; active method; base; community setting; cost; cost effectiveness; craving; depression; design; economic cost; effectiveness trial; efficacy trial; evidence base; health economics; methadone maintenance; nicotine craving; nicotine patch; nicotine replacement; prevent; primary outcome; public health relevance; response; smoking cessation; standard care; treatment duration; treatment effect; trial comparing

DESCRIPTION (provided by applicant): The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe. Yet, abstinence rates following patch treatment are only ~20% at 6-months and ~9% at 12-months. There is a growing recognition that nicotine dependence is a chronic disease, like asthma or diabetes, which requires maintenance therapy. While current guidelines established by the US DHHS's Public Health Service (PHS) recommend 8-week duration for transdermal nicotine therapy, support for this recommendation is limited. In a recent randomized placebo-controlled efficacy trial comparing standard (8-week) vs. extended (24- weeks) treatment with nicotine patches, we found that, at 24 weeks, point-prevalence abstinence rates were 30% in the 24-week arm vs. 20% in the standard therapy arm (p < .05); however, by week 52, 6 months after treatment was discontinued for the extended treatment arm, the quit rates were equivalent across the treatment arms. This was the first clinical trial to suggest that the benefits of extended treatment with transdermal nicotine are largely dependent on the continuation of active treatment. However, as an efficacy trial, this study was conducted under highly-controlled conditions with strict inclusion/exclusion criteria to enhance internal validity. If recommendations for the duration of nicotine patch therapy are to be formally revised to encourage maintenance therapy, these findings must be replicated and extended under "real-world circumstances" in an effectiveness trial. In addition, as done in clinical trials to support the use of methadone maintenance for opiate dependence, a replication study must include a treatment arm that receives maintenance therapy throughout the duration of the trial (52 weeks). Thus, we propose to conduct a randomized effectiveness trial to evaluate the benefits of maintenance therapy with transdermal nicotine patches for smoking cessation. Specifically, 660 smokers will receive brief counseling and will be randomized to: standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) transdermal nicotine therapy. The primary outcome will be bio-chemically verified 7-day point prevalence abstinence at week 52. Additional study aims include assessing: 1) treatment side effects across study arms; 2) longitudinal patterns of relapse and recovery across treatment arms; 3) mediators and moderators of treatment effects; and 4) cost-effectiveness. Overall, the trial findings will provide critical data for future PHS reviews of maintenance therapy with transdermal nicotine for subsequent treatment guidelines; for third-party payer assessments of maintenance transdermal nicotine as a covered benefit; and for individual smokers' decisions to use maintenance transdermal nicotine through over-the-counter access. In turn, this study may help to attain the Healthy People 2010 goals of reducing the US rate of tobacco use. PUBLIC HEALTH RELEVANCE: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 660 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is bio-chemically verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.

描述（由申请人提供）：透皮尼古丁贴片是美国和欧洲最广泛使用的烟草依赖治疗形式。但是，在6个月时，补丁治疗后的禁欲仅为20％，而在12个月中的节制率约为9％。人们越来越认识到尼古丁依赖性是一种慢性疾病，例如哮喘或糖尿病，需要维持治疗。尽管美国DHHS公共卫生服务（PHS）制定的当前指南建议透皮尼古丁疗法为期8周的时间，但对此建议的支持是有限的。在最近的一项随机安慰剂对照试验中，比较了标准（8周）与尼古丁斑块的延长（24周）治疗，我们发现，在24周中，在24周中，在标准治疗组中，在24周中，差异为30％（p <.05）；然而，到第52周，在治疗部门停止治疗后6个月，戒烟率在整个治疗臂上相当。这是第一个临床试验，表明使用透皮尼古丁治疗的益处在很大程度上取决于持续的主动治疗。但是，作为一项疗效试验，这项研究是在高度控制的条件下进行的，具有严格的包含/排除标准以提高内部有效性。如果要对尼古丁补丁疗法的建议进行正式修订以鼓励维护治疗，则必须在有效试验中复制和扩展这些发现。此外，正如在临床试验中支持使用美沙酮维持鸦片依赖性的那样，复制研究必须包括在整个试验期间接受维护治疗的治疗组（52周）。因此，我们建议进行一项随机有效性试验，以评估透皮尼古丁斑块维持治疗的益处，以戒烟。具体来说，有660名吸烟者将获得简短的咨询，并将随机分配给：标准（8周），延长（24周）或维护（52周）透皮尼古丁治疗。主要结果将是在第52周对生物化学验证的7天点戒烟。其他研究的目的包括评估：1）研究臂之间的治疗副作用； 2）跨处理臂复发和恢复的纵向模式； 3）治疗效果的介体和主持人； 4）成本效益。总体而言，试验结果将为未来的PHS评论提供关键数据，以透皮尼古丁的维持治疗评估，以获取随后的治疗指南；用于维护透皮尼古丁的第三方付款人评估；并为个别吸烟者的决定，可以通过非处方访问使用维护透皮尼古丁。反过来，这项研究可能有助于实现2010年健康人的目标，即降低美国使用烟草的利率。公共卫生相关性：透皮尼古丁贴片是美国和欧洲最广泛使用的烟草依赖性治疗形式，但是大多数吸烟者无法成功使用这种治疗形式。未能对此治疗做出反应，可能在很大程度上是由于仅在8周内使用尼古丁斑块，即建议的治疗时间。我们在一项受控的随机临床试验中发现，使用尼古丁贴片24周可以大大提高戒烟率。我们在这里提出了一项临床试验，将这些结果复制并扩展到现实世界中的社区环境，使用在临床试验中使用的相同研究设计，以证明美沙酮维持治疗对鸦片依赖性的有效性。具体来说，有660名吸烟者将获得咨询和标准（8周），延长（24周）或透皮尼古丁斑块的维护（52周）治疗。主要结果是在第52周进行生物化学验证的戒烟。还将评估成本效益，安全性和效果机理（例如，促进恢复后的恢复后促进恢复）用于维持透皮尼古丁的维持治疗。研究结果可能会改变我们如何用透皮尼古丁治疗尼古丁依赖性。