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

项目总结/摘要 这个项目是为了证明一种新的治疗阿片类药物成瘾，如DSM 5所定义的， 是安全的，并且当用作独立治疗时，远远上级假对照治疗。 这种治疗方法有望大大有助于对抗阿片类药物的流行， 肆虐着我们的国家和世界治疗包括使用4分钟的 应用单侧经颅光生物调节，近红外模式，通过 超发光的LED，在前额的一侧，我们确定， （通过专有测试）有一个更积极的情绪效价。基于鲁棒 初步数据，包括已完成的已发表的I期研究，我们预计， 治疗将非常有效地减少药物使用和复发以及渴望， 临床状态和功能。目标我将提供一次或两次每周（在相同的数字） 治疗两组，积极和假，25周，每周随访1次，将寻找 特别是阿片类药物戒断，阿片类药物使用，渴望和一般心理 功能状态。所有患者在入组时都将使用阿片类药物， 阿片类药物使用障碍治疗。我们将密切评估患者的安全性和有效性， 书房在Aim II中，我们将与合作开发通过监管要求的LED器件 申请FDA的突破性治疗我们将与FDA合作， 最终获得批准用于阿片类药物使用障碍的治疗。MindLight的执行官 团队将与加勒特科技公司密切合作。业务和工程人员， 最终实现成功的商业化，使新的治疗方法可以广泛地 提供给有需要的人。该疗法基于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很好地支持了 这些理论。

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.