Extended Cessation Treatment for Teen Smokers

青少年吸烟者的长期戒烟治疗

• 批准号: 7473143
• 负责人: JOEL D KILLEN
• 金额: $ 50.09万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7473143
• 关键词: Abstinence; Address; Adolescent; Age; Air; Area; Carbon Monoxide; Cigarette; Combined Modality Therapy; Community Health; Counseling; Count; Early Diagnosis; Effectiveness; Eligibility Determination; Failure; Goals; Knowledge; Label; Medical; Outcome; Outcome Measure; Participant; Pharmaceutical Preparations; Phase; Population Study; Prevalence; Randomized; Randomized Clinical Trials; Range; Rate; Relapse; Reporting; San Francisco; Smoker; Smoking; System; Target Populations; Teenagers; Telephone; Time Study; Voice; Week; Withholding Treatment; aged; anti-smoking; base; day; follow-up; high school; nicotine patch; nicotine replacement; non-smoking; programs; psychologic; response; skills training; smoking cessation

DESCRIPTION (provided by applicant): Adolescent smokers (aged 14-18; > 10 cigarettes/day) attending continuation high schools in the San Francisco-San Jose Bay Area will serve as the target population for this study. 400 smokers meeting eligibility criteria will be randomized. Our primary goal is to examine the effectiveness of a multi-factor extended treatment strategy in promoting longer-term smoking abstinence. AN 400 smokers will receive 10 weeks of open label treatment consisting of nicotine patch therapy and group-based, intensive self- regulatory skills training (ST). Following open label treatment, half (n=200) will receive nine additional group-based ST sessions delivered over a 14 week period. Telephone counseling will also be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=200) will not receive any additional therapy beyond that provided in the open label treatment phase. Abstinence and relapse will be assessed at the end of open label (10 weeks) and extended treatment (24 weeks) and at 52 weeks from the time of study entry. Our primary hypothesis is that smokers randomized to extended treatment will have a higher prolonged abstinence rate (PA) at 25 week follow-up than participants receiving only open label treatment. PA at 25 weeks will be the outcome measure used to evaluate the primary hypothesis and will be defined as a report of non-smoking following an initial 2-week grace period during which any smoking is not counted as a failure. Here, failure is defined as either seven consecutive days of smoking or smoking on at least one day on each of two consecutive weeks. Point prevalence abstinence will be examined as a secondary outcome and defined as no smoking, not even a puff, for seven consecutive days prior to assessment and an expired-air carbon monoxide level of <9PPM. The proposed study will address several important gaps in our knowledge of how to help adolescent smokers quit smoking. First, to our knowledge, the study will be the first to examine the effects of a longer- lasting cessation program for adolescent smokers. Second, the study will be one of the first to combine psychological treatment and anti-smoking medication for adolescent smokers. Third, the trial will carefully examine a range of factors that may help or hinder adolescent smokers' ability to quit smoking. The study will provide important practical information to the medical and health communities concerning the usefulness of anti-smoking medication and psychological treatment in helping adolescent smokers to quit.

描述（由申请人提供）：在旧金山 - 南何塞湾地区的连续高中就读青少年吸烟者（年龄14-18岁；> 10支香烟/天）将作为这项研究的目标人群。 400名满足资格标准的吸烟者将被随机分配。我们的主要目标是研究多因素扩展治疗策略在促进长期戒烟方面的有效性。 400名吸烟者将接受10周的开放式标签治疗，包括尼古丁贴片疗法和基于小组的强化自我调节技能培训（ST）。在开放标签处理后，一半（n = 200）将在14周内进行九个基于组的ST会议。电话咨询还将与交互式语音响应系统（IVR）一起提供，该系统将允许早期发现吸烟“滑动”和治疗人员快速响应。另一半（n = 200）将不会获得超出开放标签治疗阶段提供的任何其他疗法。节制和复发将在开放标签（10周）和延长治疗（24周）以及从研究入学开始的52周结束时进行评估。我们的主要假设是，与仅接受开放标签治疗的参与者相比，在25周随访时，随机进行延长治疗的吸烟者将在25周的随访中延长节制率（PA）。 25周的PA将是用于评估主要假设的结果措施，并将定义为在最初为期2周的宽限期之后不吸烟的报告，在此期间，任何吸烟都不被视为失败。在这里，失败定义为连续两周的至少一天的吸烟连续七天或吸烟。点的禁欲将被视为次要结果，并定义为在评估前连续七天连续七天和过期的空气一氧化碳水平<9ppm的未吸烟，甚至没有吹气。拟议的研究将解决我们有关如何帮助青少年吸烟者戒烟的一些重要差距。首先，据我们所知，该研究将是第一个研究较长持久计划对青少年吸烟者的影响的研究。其次，这项研究将是最早将心理治疗和抗吸烟药物结合给青春期吸烟者的研究之一。第三，该试验将仔细检查可能有助于或阻碍青春期吸烟者戒烟能力的一系列因素。这项研究将为医学和健康社区提供有关抗吸烟药物和心理治疗方法在帮助青少年吸烟者戒烟的有用性的重要实用信息。