Medicinal nicotine for preventing stress induced craving and withdrawal symptoms

药用尼古丁用于预防压力引起的渴望和戒断症状

• 批准号: 8111608
• 负责人: MICHAEL KOTLYAR
• 金额: $ 21.82万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8111608
• 关键词: Abstinence; Acute; Address; Applications Grants; Area; Attenuated; Cessation of life; Clinical Trials; Counseling; Cues; Data; Exposure to; Goals; Hour; Instruction; Intervention; Knowledge; Laboratories; Laboratory Study; Lead; Measures; Modeling; Nicotine; Nicotine Withdrawal; Pharmaceutical Preparations; Randomized; Relapse; Relative (related person); Reporting; Research; Schedule; Severities; Smoker; Smoking; Stress; Symptoms; Time; Tobacco; Tobacco Dependence; Translating; United States; Withdrawal; Withdrawal Symptom; Work; base; comparative efficacy; cost; craving; experience; improved; innovation; nicotine craving; nicotine patch; nicotine replacement; prevent; smoking cessation; stressor; success; trial comparing

DESCRIPTION (provided by applicant): Although most smokers indicate a desire to quit smoking, fewer than 30% achieve long term abstinence using currently available treatments. New treatments for tobacco dependence have been introduced rarely with only two non-nicotine pharmacological aids available. The low smoking cessation success rates and the infrequent introduction of new therapies necessitate that the efficacy of currently available therapies be maximized. Nicotine lozenge is often recommended to be used on an as needed basis with smokers generally told to use the nicotine lozenge when craving or withdrawal symptoms occur. Nicotine concentrations however do not increase substantially until about 10 minutes after nicotine lozenge use and do not peak until approximately 30 minutes after starting use. For subjects experiencing acute symptoms of craving or withdrawal, this delay may be too long to prevent relapse. There are a number of smoking triggers that have been demonstrated in laboratory studies to increase craving and in naturalistic studies to precede smoking lapses. One of the two most commonly cited smoking triggers is the presence of a stressful situation. It is not currently known if use of the nicotine lozenge prior to being exposed to a stressful task attenuates the increase in craving that subjects frequently experience during stress. To address this issue and to identify the time-frame (relative to the stressor) during which a nicotine lozenge should be used, a laboratory study is proposed in which craving and withdrawal symptoms will be measured prior and subsequent to a stress task. Each subject will have one laboratory session at which nicotine lozenge is given immediately after the stressor (to approximate current recommended use of NRT - i.e. after craving and withdrawal symptoms occur) and will be randomized to one laboratory session at which nicotine lozenge will be given either a) immediately prior to; b) 10 minutes; c) 20 minutes; or d) 30 minutes prior to the stressor. Data from this study identifying the optimal time-frame for nicotine lozenge administration will be used in a subsequent grant application to assess if counseling smokers to use nicotine lozenge in anticipation of a smoking trigger results in higher cessation rates than the current practice of counseling smokers to use these products when they need them (i.e. after symptoms of craving or withdrawal have already occurred). Ultimately this line of research should lead to more effective use of medicinal nicotine and higher smoking cessation success rates. PUBLIC HEALTH RELEVANCE: The planned study would determine if using nicotine lozenge prior to a stress task attenuates the increase in symptoms of tobacco craving and withdrawal that occurs when smokers are presented with stressful situations. Such information could lead to changes in the instructions given to smokers about when they should use nicotine lozenge, thereby making it more effective in helping smokers successfully quit.

描述（由申请人提供）：尽管大多数吸烟者表示希望戒烟，但使用目前可用的治疗方法，只有不到30%的人实现了长期戒烟。新的烟草依赖治疗方法很少采用，只有两种非尼古丁药理学辅助药物可用。戒烟成功率低，新疗法的引入不频繁，因此必须最大限度地提高现有疗法的疗效。尼古丁含片通常建议根据需要使用，吸烟者通常被告知在出现渴望或戒断症状时使用尼古丁含片。然而，尼古丁浓度直到尼古丁含片使用后约10分钟才显著增加，并且直到开始使用后约30分钟才达到峰值。对于经历渴望或戒断的急性症状的受试者，这种延迟可能太长而不能防止复发。实验室研究表明，有许多吸烟诱因会增加烟瘾，自然主义研究表明，这些诱因会导致吸烟失误。两个最常被引用的吸烟诱因之一是压力环境的存在。目前尚不清楚在暴露于压力任务之前使用尼古丁含片是否会减弱受试者在压力期间经常经历的渴望的增加。为了解决这个问题，并确定时间框架（相对于应激源），在此期间，尼古丁含片应使用，实验室研究中提出的渴望和戒断症状将测量之前和之后的压力任务。每例受试者将接受一次实验室治疗，在应激源后立即给予尼古丁含片（接近目前推荐的NRT使用-即在出现渴望和戒断症状后），并将被随机分配至一次实验室治疗，在应激源前a）即刻; B）10分钟; c）20分钟;或d）30分钟给予尼古丁含片。本研究确定尼古丁含片给药最佳时间范围的数据将用于后续的资助申请，以评估咨询吸烟者在预期吸烟触发因素时使用尼古丁含片是否比咨询吸烟者在需要时使用这些产品（即，在已经出现渴望或戒断症状后）的当前做法更高的戒烟率。最终，这一系列研究应该会导致更有效地使用药用尼古丁和更高的戒烟成功率。 公共卫生关系：计划中的研究将确定在压力任务之前使用尼古丁含片是否会减弱吸烟者在压力情况下出现的烟草渴望和戒断症状的增加。这些信息可能会导致改变给吸烟者的关于何时应该使用尼古丁含片的说明，从而使其更有效地帮助吸烟者成功戒烟。