Intranasal insulin for the treatment of alcohol use disorder: design and methodology of an alcohol interaction randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-06-10 DOI:10.1016/j.conctc.2025.101509

Carolina L. Haass-Koffler , Bhavani Kashyap , Brian J. Gully , Sithara S. Nambiar , Rivkah Hornbacher , Stephanie L. Foster , Yuval Silberman , Robert M. Swift , Leah R. Hanson , William H. Frey II

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引用次数: 0

Abstract

Despite developments in treatments for alcohol use disorder (AUD), current pharmacotherapies face several limitations, including adverse events. Intranasal (IN) insulin has shown promise for addictive disorders. The overarching hypothesis of this trial is that by increasing brain cell energy and glucose metabolism, while reducing stress hormones, IN insulin may be an ideal approach for treating multiple domains of AUD including memory, executive function and impulsivity. Preclinical and clinical studies of IN insulin demonstrate that it is a safe and effective method for delivering insulin to the central nervous system, circumventing the blood brain barrier, and reducing adverse events associated with insulin use (hypoglycemia). The overarching goal of this Phase I/IIa, within-subject, crossover, double-blind, placebo-controlled, alcohol interaction trial is to test the IN insulin (80IU), compared to placebo (0.9 % saline) as a potential therapy for AUD. The primary aim assesses the safety and tolerability of IN insulin, compared to placebo, in individuals with AUD (N = 40) who are not currently seeking treatment. The secondary aim assesses the safety and tolerability of IN insulin, compared to placebo, when co-administered with alcohol (0.08 g/dL). Tertiary aims include assessing cognitive performance, memory, and impulsivity following IN insulin, or placebo, and alcohol administration. Finally, an alcohol cue reactivity procedure investigates the effect of IN insulin, compared to placebo, in alcohol craving. This is the first study to evaluate IN insulin in an AUD population and this manuscript describes the rationale, design, and methodology of the alcohol interaction trial. This study is designed to accelerate research for the development of novel medications to treat AUD and provide empirical evidence on the safety and efficacy of a neurotherapeutic approach to inform clinical practice.

Clinical trial

NCT05988632.

Fda/ind

168417.

查看原文本刊更多论文

鼻内胰岛素治疗酒精使用障碍：酒精相互作用随机对照试验的设计和方法

尽管酒精使用障碍（AUD）的治疗方法有所发展，但目前的药物治疗仍面临一些局限性，包括不良事件。鼻内胰岛素（IN）已显示出治疗成瘾性疾病的希望。本试验的首要假设是，通过增加脑细胞能量和葡萄糖代谢，同时减少应激激素，胰岛素可能是治疗AUD多个领域的理想方法，包括记忆、执行功能和冲动。IN胰岛素的临床前和临床研究表明，它是一种安全有效的方法，可以将胰岛素输送到中枢神经系统，绕过血脑屏障，减少与胰岛素使用相关的不良事件（低血糖）。这项I/IIa期、受试者内、交叉、双盲、安慰剂对照、酒精相互作用试验的总体目标是测试IN胰岛素（80IU）与安慰剂（0.9%生理盐水）作为AUD的潜在治疗方法。主要目的是评估目前未寻求治疗的AUD患者（N = 40）与安慰剂相比使用IN胰岛素的安全性和耐受性。第二个目的是评估与安慰剂相比，与酒精（0.08 g/dL）联合给药时胰岛素的安全性和耐受性。第三目的包括评估胰岛素、安慰剂和酒精治疗后的认知表现、记忆力和冲动性。最后，酒精提示反应程序研究了胰岛素对酒精渴望的影响，并与安慰剂进行了比较。这是第一项评估AUD人群中IN胰岛素的研究，本文描述了酒精相互作用试验的基本原理、设计和方法。本研究旨在加速研究开发治疗AUD的新药物，并为神经治疗方法的安全性和有效性提供经验证据，为临床实践提供信息。临床trialNCT05988632.Fda / ind168417。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.