BUPROPION TREATMENT FOR YOUTH SMOKING CESSATION

安非他酮治疗青少年戒烟

• 批准号: 2546999
• 负责人: SCOTT J LEISCHOW
• 金额: $ 39.06万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2001-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2546999
• 关键词: adolescence (12-20); clinical research; clinical trial phase I; dopamine agonists; dosage; drug screening /evaluation; drug withdrawal; gender difference; health; human subject; outcomes research; racial /ethnic difference; smoking cessation; socioeconomics

DESCRIPTION: (Applicant's Description) Tobacco use remains the leading preventable cause of premature death in the U.S., and this public health problem will remain so if advances in the treatment of nicotine dependence do not occur. While the approved medications for smoking cessation to date are those that provide nicotine replacement, recent studies evaluating the effects of novel non-nicotine medications suggest that significant improvements in cessation rates may be possible. One of the most promising non-nicotine medications is bupropion (Zyban). Bupropion has been available as an antidepressant that increases dopamine availability and thus elevates mood, and will be FDA approved as a smoking cessation medication. Furthermore, it has been investigated as a medication for the treatment of attention deficit/hyperactivity disorder in youth. Because the efficacy of bupropion for adult smoking cessation is greater than nicotine replacement, and because the safety of bupropion has been shown in youth, it is the clear choice for investigation as a pharmacologic treatment for youth smoking cessation. Since the optimal dose for smoking cessation has not been assessed in youth, a dose ranging study to evaluate the safety and efficacy of bupropion for smoking cessation in youth is proposed. The proposed study is a randomized, double-blind, placebo-controlled clinical trial designed to assess (1) which bupropion dose, if any, increases abstinence rates over placebo, and (2) which factors, such as medication adherence, nicotine dependence, and motivation to quit, affect treatment outcome. There are a number of potential benefits from the proposed study. The results of the proposed study could lead to a better understanding of how to use a pharmacologic treatment for youth smoking cessation. Initiation of tobacco use is largely a sociocultural process, nicotine dependence is a medical condition whose treatment is optimized when the full armamentarium of medical care is provided. The proposed study will follow Agency for Health Care Policy and Research guidelines for smoking cessation, including a medical model approach that combines behavioral and pharmacologic intervention within a health care environment. While many studies have evaluated cessation methods for adults, there remains a dearth of research evaluating methods for enhancing youth smoking cessation. With so little research upon which to expand, the proposed study could lead to important new understandings regarding the process and mechanisms of youth smoking cessation.

描述：（申请人的描述） 烟草使用仍然是导致过早死亡的主要预防原因 美国，这个公共卫生问题将仍然存在，因此，如果 尼古丁依赖性的治疗不会发生。 同时获得批准 迄今为止戒烟的药物是提供尼古丁的药物 替代，最近的研究评估了新型非核苷的影响 药物表明，停止率的显着提高可能是 可能的。 最有前途的非新核药物之一是安非他酮（Zyban）。 安非他酮已作为抗抑郁药可用，增加了多巴胺 可用性，从而提高情绪，并将被FDA批准为吸烟 停止药物。 此外，已被研究为药物 为了治疗青少年注意力不足/多动症。 因为安非他酮对成人戒烟的功效更大 比尼古丁的替代品，因为安非他酮的安全 在青年中显示，这是作为药理学调查的明确选择 青年戒烟的治疗。 由于吸烟的最佳剂量 尚未在年轻人中评估停止，这是一项评估的剂量范围的研究 安非他酮在青年中戒烟的安全性和功效是 建议的。 拟议的研究是一项随机，双盲的研究 安慰剂控制的临床试验旨在评估（1）哪种安非他酮 剂量（如果有的话）增加了与安慰剂相比的禁欲，以及（2） 因素，例如药物依从性，尼古丁依赖和动机 退出，影响治疗结果。 拟议的研究有许多潜在的好处。 这 拟议的研究的结果可能会更好地了解如何 使用药理学治疗以戒烟。 启动 烟草使用主要是一种社会文化过程，尼古丁依赖性是 整个Armammentium时，医疗状况优化了治疗 提供医疗服务。 拟议的研究将跟随机构 戒烟的医疗保健政策和研究指南，包括 一种结合行为和药理学结合的医学模型方法 在医疗保健环境中进行干预。 虽然许多研究有 评估了成人的戒烟方法，仍然缺乏研究 评估增强青年戒烟的方法。 很少 可以扩展的研究，拟议的研究可能导致重要 关于青年吸烟的过程和机制的新理解 停止。