Efficacy of Intranasal Insulin in Relieving Symptoms of Tobacco Abstinence Syndro

描述（由申请人提供）：复燃的最高发生率发生在戒烟尝试的前两周。戒烟的最初阶段以记忆功能障碍和压力反应增加为特征。许多吸烟者无法克服这些症状，他们在试图戒烟后不久又重新吸烟。最近的研究结果表明，中枢神经系统中的胰岛素可以抑制应激反应，改善健康受试者和阿尔茨海默病患者的记忆功能。在这些研究中，胰岛素是经鼻给药到中枢神经系统，没有观察到明显的低血糖发作。鼻内胰岛素从未在尼古丁依赖研究参与者中进行过研究。由于记忆功能障碍和应激反应性增加是尼古丁戒断的重要方面，鼻内胰岛素对这两个领域的积极作用可能会改善戒烟治疗的结果。在一项随机、双盲、I期研究（N=70）中，我们将检验一个假设，即鼻内胰岛素将：1改善情景记忆功能障碍；抑制应激反应；对急性戒烟者安全可行。通过鼻内给药增加脑胰岛素水平可能是缓解尼古丁戒断症状的一种有希望的方法。

DESCRIPTION (provided by applicant): The highest incidence of relapse to smoking occurs within the first 2 weeks of a cessation attempt. This initial phase of smoking cessation is marked by memory dysfunction and increased stress reactivity. Many smokers are not able to overcome these symptoms, and they relapse to smoking shortly after trying to quit. Results of recent studies show that insulin in the Central Nervous System dampens stress response and improves memory function in both healthy subjects as well as Alzheimer's disease patients. Insulin in these studies was delivered to the Central Nervous System intranasally, and no significant episodes of hypoglycemia were observed. Intranasal insulin has never been studied in nicotine dependent research participants. As memory dysfunction and increased stress reactivity are important aspects of nicotine withdrawal, intranasal insulin's positive effect on these two domains may improve smoking cessation treatment outcomes. In a randomized, double-blind, Phase I study (N=70), we will be testing a hypothesis that intranasal insulin will: 1 improve episodic memory dysfunction, 2. dampen stress response, 3. be safe and feasible to administer to acutely abstinent smokers. Increasing brain insulin levels by intranasal administration may be a promising approach for relieving symptoms of nicotine withdrawal.