Efficacy of Intranasal Insulin in Relieving Symptoms of Tobacco Abstinence Syndro

鼻内胰岛素缓解戒烟综合症症状的功效

• 批准号: 8702860
• 负责人: Ajna Hamidovic
• 金额: $ 7.55万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8702860
• 关键词: Abstinence Syndrome; Acute; Adrenal Cortex Hormones; Adverse event; Alzheimer' s Disease; Animals; Attention; Binding; Brain; California; Chantix; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Cognitive; Communities; Conduct Clinical Trials; Data; Distress; Double-Blind Method; Episodic memory; Evaluation; Event; FDA approved; Foundations; Functional disorder; Future; Glucocorticoid Receptor; Glucocorticoids; Glutamates; Hippocampus (Brain); Human; Hydrocortisone; Hypoglycemia; Incidence; Insulin; Intranasal Administration; Memory; Meta-Analysis; Monitor; Morbidity - disease rate; Nasal cavity; Neuraxis; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Olfactory Nerve; Outcome; Participant; Pathway interactions; Patients; Peptides; Performance; Phase; Placebo Control; Placebos; Randomized; Reaction Time; Relapse; Research; Research Methodology; Route; Safety; Short-Term Memory; Smoker; Smoking; Specific qualifier value; Stress; Symptoms; Testing; Texas; Time; Tobacco; Treatment Efficacy; Treatment outcome; Trier Social Stress Test; Universities; Verbal Learning; Withholding Treatment; absorption; addiction; base; biological adaptation to stress; cohort; frontal lobe; human subject protection; improved; mortality; non-smoker; phase 1 study; public health relevance; receptor; research study; smoking cessation; tobacco abstinence; transmission process; varenicline

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.

描述(由申请者提供)：戒烟尝试后的头两周内，复吸率最高。戒烟的最初阶段表现为记忆功能障碍和应激反应增强。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抑制了应激反应，并改善了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，胰岛素通过鼻腔输送到中枢神经系统，没有观察到明显的低血糖事件。鼻腔胰岛素从未在尼古丁依赖的研究参与者中被研究过。由于记忆障碍和应激反应增强是尼古丁戒断的重要方面，鼻内胰岛素在这两个方面的积极作用可能会改善戒烟治疗的结果。在一项随机、双盲的I期研究中(N=70)，我们将检验一种假设，即鼻腔注射胰岛素将：1改善间歇性记忆功能障碍；2.抑制应激反应；3.对急性戒烟者安全可行。通过鼻腔给药提高脑内胰岛素水平可能是缓解尼古丁戒断症状的一种有前途的方法。