BUPROPION TREATMENT FOR YOUTH SMOKING CESSATION

描述：(申请人描述) 烟草使用仍然是可预防的过早死亡的主要原因 这一公共卫生问题将继续存在，如果在 尼古丁依赖的治疗不会发生。而经批准的 迄今为止，用于戒烟的药物是那些提供尼古丁的药物。 替代，最近的研究评估了新型非尼古丁的效果 药物治疗表明，戒断率的显著提高可能是 有可能。 最有前景的非尼古丁药物之一是安非他酮(Zyban)。 安非他酮已被用作增加多巴胺的抗抑郁剂 可供使用，从而提升情绪，并将被FDA批准为吸烟 戒烟药物。此外，它还被作为一种药物进行了研究 用于治疗青少年的注意力缺陷/多动障碍。 因为安非他酮对成人戒烟的效果更好 尼古丁替代，因为安非他酮的安全性 在青年时期表现出来，是作为药理学研究的明确选择 青少年戒烟治疗。由于吸烟的最佳剂量 尚未对年轻人进行戒烟评估，这是一项评估剂量范围的研究 安非他酮用于青少年戒烟的安全性和有效性是 建议。建议的研究是一项随机、双盲、 安慰剂对照临床试验旨在评估(1)哪种安非他酮 剂量，如果有的话，比安慰剂增加禁酒率，和(2)哪一个 因素，如服药依从性、尼古丁依赖和动机 戒烟，影响治疗结果。 这项拟议的研究有许多潜在的好处。这个 拟议研究的结果可能有助于更好地理解如何 使用药物治疗青少年戒烟。发起 烟草使用在很大程度上是一个社会文化过程，尼古丁依赖是一种 医疗条件得到优化的时候，满的医疗机构 所提供的医疗服务。拟议的研究将遵循该机构的 卫生保健政策和戒烟研究指南，包括 结合行为学和药理学的医学模型方法 在卫生保健环境中进行干预。虽然许多研究都有 对成人戒烟方法的评估仍然缺乏研究 促进青少年戒烟的评估方法。这么少的钱 在需要扩展的研究的基础上，拟议的研究可能导致重要的 对青少年吸烟过程和机制的新认识 停止。

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.