A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.

项目摘要/摘要 这个项目是为了证明DSM 5定义的一种治疗阿片成瘾的新方法， 作为一种单独的治疗方法，它是安全的，而且远远优于假对照治疗。 这种治疗有望大大有助于抗击鸦片类药物流行的斗争，即 肆虐我们国家和世界的大部分地区。治疗包括使用4分钟的 单侧经颅光生物调节的应用，近红外线模式，通过 超亮LED，位于额头一侧的大脑半球，我们确定 (通过专有测试)拥有更积极的情感价值。基于健壮性 初步数据，包括已完成的、已公布的第一阶段研究，我们预计 治疗将非常有效地减少药物使用和复发以及对药物的渴望，总体上 临床状态和功能。AIM我将每周提供一到两次(同等数量) 对两组进行为期25周的治疗，包括活动组和假组，每周随访1次，并将 特别是在阿片类药物戒断、阿片类药物使用、渴望和一般心理方面的差异 和正常运作的状态。所有患者在登记时都将使用阿片类药物，并且将不会 阿片类药物使用障碍的治疗。我们将密切评估患者的安全性和有效性 这项研究。在AIM II中，我们将与之合作开发通过监管要求的LED设备 并申请FDA突破性治疗指定。我们将与FDA合作，争取 最终批准这种阿片类药物使用障碍的治疗。MindLight的高管 团队将与Garrett Technologies，Inc.的业务和工程人员密切合作， 实现最终的、成功的商业化，这样新的治疗方法可能会得到广泛的应用 提供给有需要的人。这种疗法是基于MindLight创始人的假设 心理学理论、双脑心理学和已发表的实验都得到了很好的支持 那些理论。

Project Summary/Abstract This project is to demonstrate that a novel treatment for opiate addiction, as defined by DSM 5, is safe and far superior to a sham comparison treatment when used as a stand-alone treatment. The treatment is hoped to significantly aid in the battle against the opiate epidemic that is ravaging much of our country and the world. The treatment consists of using a 4-minute application of unilateral transcranial photobiomodulation, near infra-red mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that we determine (through a proprietary test) to have a more positive emotional valence. Based on robust preliminary data, including a completed, published Phase I study, we anticipate that the treatment will be very effective in reducing drug use and relapses as well as cravings, and overall clinical state and functioning. Aim I will offer once or twice weekly (in equal numbers) treatments to two groups, active and sham, for 25-weeks with 1 weekly follow-up and will look specifically for differences in opioid abstinence, opioid use, cravings, and general psychological and functioning state. All the patients will be using opioids at enrollment and will be on no opioid use disorder treatment. We will evaluate patients closely for safety and efficacy during the study. In Aim II we will work with to develop LED devices that pass regulatory requirements and apply for an FDA breakthrough treatment designation. We will work with the FDA toward achieving eventual approval for this treatment of opioid use disorder. MindLight’s executive team will work closely with Garrett Technologies, Inc. business and engineering personnel, to achieve eventual, successful commercialization so that the novel treatment might become widely available to those in need. The therapy is based on hypotheses from the MindLight founder’s psychological theory, Dual-Brain Psychology, and published experiments have well supported those theories.