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

基本信息

批准号：
8333332
负责人：
MICHAEL KOTLYAR
金额：
$ 18.88万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-15 至 2014-06-30
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：虽然大多数吸烟者表示希望戒烟，但只有不到 30% 的人使用目前可用的治疗方法实现长期戒烟。针对烟草依赖的新疗法很少被引入，只有两种非尼古丁药物辅助剂可用。戒烟成功率低且很少引入新疗法，因此必须最大限度地发挥现有疗法的功效。通常建议根据需要使用尼古丁含片，吸烟者通常被告知在出现烟瘾或戒断症状时使用尼古丁含片。然而，直到使用尼古丁含片后约 10 分钟，尼古丁浓度才会大幅增加，并且直到开始使用后约 30 分钟才达到峰值。对于经历急性渴望或戒断症状的受试者来说，这种延迟可能太长而无法防止复发。实验室研究表明，有许多吸烟触发因素会增加吸烟的渴望，而自然主义研究则表明，吸烟会导致戒烟。最常提到的两个吸烟诱因之一是压力环境的存在。目前尚不清楚在面临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应使用尼古丁含片的时间范围（相对于压力源），提出了一项实验室研究，其中将在压力任务之前和之后测量渴望和戒断症状。每个受试者将接受一次实验室会议，在压力源后立即给予尼古丁含片（以近似当前建议使用的 NRT - 即在出现渴望和戒断症状后），并将被随机分配到一次实验室会议，在该实验室会议中将给予尼古丁含片a) 紧接之前； b) 10 分钟； c) 20 分钟；或 d) 在压力源之前 30 分钟。这项研究的数据确定了尼古丁含片给药的最佳时间范围，将用于随后的拨款申请，以评估在预期吸烟触发因素的情况下建议吸烟者使用尼古丁含片是否会比目前建议吸烟者使用尼古丁含片的做法获得更高的戒烟率。在需要时使用这些产品（即在已经出现渴望或戒断症状后）。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。