Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial

延长伐尼克兰治疗癌症患者的吸烟时间：一项临床试验

• 批准号: 8683128
• 负责人: Robert A Schnoll
• 金额: $ 59.42万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8683128
• 关键词: Abstinence; Acute; Address; Adherence; Adverse effects; Affect; Agreement; Area; Behavior Therapy; Blood; Bupropion; Cancer Center; Cancer Patient; Cancer Survivor; Clinical Trials; Cognition; Comprehensive Cancer Center; Data; Development; Diagnosis; Double-Blind Method; Effectiveness; Evaluation; Evidence based treatment; Exhibits; General Population; Guidelines; Health; Impaired cognition; Intervention; Literature; Measures; Mediating; Mediator of activation protein; Medical; Mental Depression; Modeling; Nicotine Dependence; Nurses; Patients; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Placebo Control; Placebos; Population; Prevalence; Primary Neoplasm; Process; Quality of life; Recording of previous events; Recovery; Recruitment Activity; Relapse; Research; Risk; Second Primary Cancers; Site; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Staging; Testing; Time; TimeLine; Tobacco; Tobacco use; Treatment Efficacy; United States National Institutes of Health; United States Public Health Service; Withholding Treatment; base; cancer care; cancer diagnosis; cognitive function; design; effective therapy; experience; improved; innovation; meetings; nicotine patch; novel; placebo controlled study; programs; psychological distress; smoking cessation; standard care; treatment duration; treatment effect; treatment program; tumor; varenicline

DESCRIPTION (provided by applicant): Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke following diagnosis and treatment. Continued smoking by cancer patients reduces survival time, medical treatment efficacy, and quality of life (QOL). To date, studies of smoking cessation interventions for cancer patients have failed to yield significant treatment effects. As such, currently, there is no evidence-based treatment model for addressing tobacco use in this population. With medical advances in cancer care yielding a growing constituency of cancer survivors - close to 12 million today - addressing nicotine dependence in this population is a priority. A recent NCI meeting called for the evaluation of novel treatments for nicotine dependence among cancer patients which address the unique barriers to cessation evident in this population, including: a high level of nicotine dependence, high levels of psychological distress and cognitive impairment, and a protracted relapse timeline. While PHS guidelines recommend acute treatment durations with approved medications for tobacco use, we have shown that extending the duration of treatment beyond the standard treatment duration significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to abstinence following a lapse. Extended duration treatment is particularly efficacious for smokers with high levels of nicotine dependence and cognitive impairment, vs. standard duration treatment, and increases quit rates for smokers with high levels of psychological distress. Varenicline, vs. other medications for smoking, may be particularly effective for cancer patients given the drug's beneficial effects on affect ad cognition. Thus, using a double-blind placebo- controlled design with 374 cancer patients we will: 1) Compare standard varenicline treatment (12-weeks active + 12-weeks placebo) to extended varenicline treatment (24-weeks active) for increasing week 24 and week 52 biochemically-confirmed 7-day point prevalence abstinence~ 2) Assess the effects of extended varenicline therapy on QOL, including varenicline side effects~ and 3) Assess changes in affect and cognitive impairment as mediators of extended varenicline therapy's effect on quit rates. We will also explore potential moderators of the effect of extended varenicline treatment on quit rates (e.g., tumor site and stage, time since diagnosis, treatment history, level of nicotine dependence). This study is significant by addressing a population with high smoking rates, which has been under-studied in the area of nicotine dependence treatment, and is at risk for unique adverse tobacco-related health effects. This study is innovative by evaluating the efficacy of extended vs. standard duration varenicline treatment, which may more effectively address unique barriers to cessation in this population. This will also be the first study to use varenicline blood levels as a measure of adherence. There is widespread agreement that evidence-based treatment programs for nicotine dependence among cancer patients are needed. This study may help guide efforts to implement such programs and help determine the benefits of extended treatment duration for nicotine dependence more broadly.

描述（由申请人提供）：在诊断和治疗后，在诊断前吸烟的癌症患者中有33-50％以上。癌症患者继续吸烟会减少生存时间，医疗效果和生活质量（QOL）。迄今为止，对癌症患者的戒烟干预措施的研究未能产生重大治疗效果。因此，目前尚无基于证据的治疗模型来解决该人群中的烟草使用。随着癌症护理的医疗进展，癌症幸存者的越来越多的选区 - 今天接近1200万 - 解决该人群中的尼古丁依赖性。 NCI最近的一次会议呼吁评估癌症患者中尼古丁依赖性的新型治疗方法，以解决该人群中明显的戒烟障碍，包括：高水平的尼古丁依赖性，高水平的心理困扰和认知障碍，以及突出的复发时间表。 虽然PHS指南建议使用经批准的烟草使用药物进行急性治疗时间，但我们表明，将治疗时间延长以外的标准治疗持续时间可显着提高退出率，降低复发的风险，并在失败后促进恢复恢复。 延长持续时间治疗对于具有高水平的尼古丁依赖性和认知障碍，与标准持续时间治疗的吸烟者特别有效，并增加了高水平心理困扰的吸烟者的戒烟率。鉴于该药物对影响AD认知的有益影响，Varenicline（与其他吸烟药物）可能特别有效。 因此，使用374名癌症患者使用双盲安慰剂控制设计，我们将：1）比较标准的Varenicline治疗（12周活跃 + 12周安慰剂）与扩展的Varenicline治疗（24周活动），以增加第24周和第52周的第52周生物化学确认的7天预期次数，以评估各种各样的varrentine and quentline conterine of quentine of Quentline consectline and Quentline of Quentine of Quentine> 2） 3）评估情感和认知障碍的变化，这是扩展的Varenicline治疗对戒烟率的影响的介体。我们还将探索潜在的主持人，即扩展Varenicline治疗对戒烟率的影响（例如肿瘤部位和阶段，诊断以来的时间，治疗史，尼古丁依赖水平）。这项研究很重要，可以解决较高的吸烟率的人群，该人口在尼古丁依赖治疗领域的研究不足，并且有独特的不良烟草相关健康影响的风险。通过评估扩展持续时间与标准持续时间治疗的功效，这项研究具有创新性，这可以更有效地解决该人群中停止的独特障碍。这也将是首次使用Varenicline血液水平作为依从性的研究。人们普遍同意，需要在癌症患者中针对尼古丁依赖性的循证治疗计划。这项研究可能有助于指导实施此类计划的努力，并有助于更广泛地确定尼古丁依赖的延长治疗持续时间的好处。