A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

摘要 这个项目是为了证明一种新的治疗阿片成瘾的方法是安全的，而且远远优于 一种虚假的对比治疗。人们希望这种治疗方法能显著帮助对抗 鸦片类药物的流行正在肆虐我们国家和世界的大部分地区。治疗包括 使用4分钟的经颅光生物调节，近红外线模式， 通过一个超发光的LED，到达我们大脑半球上额头的一侧 确定(通过专有测试)拥有更积极的情感价值。基于 初步数据显示，我们预计这项治疗将在减少毒品方面非常有效 渴望、焦虑和抑郁，以及减少复发。AIM我会每周提供两次 对两组进行为期4周的治疗，包括积极组和假组，并将专门寻找差异 阿片类药物的渴求、焦虑、抑郁和阿片类药物的使用。我们将每周对患者进行评估 治疗后3周的安全性和有效性。在AIM II中，一位备受尊敬的产品工程师 与该公司合作，设计一种可能含有专利元素的适销对路的产品。

Abstract This project is to demonstrate that a novel treatment for opiate addiction is safe and far superior to a sham comparison 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 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 preliminary data, we anticipate that the treatment will be very effective in reducing drug cravings, anxiety, and depression as well as in reducing relapses. Aim I will offer twice weekly treatments to two groups, active and sham, for 4-weeks and will look specifically for differences in opioid cravings, anxiety, depression, and opioid use. We will evaluate patients weekly for safety and efficacy for 3-weeks post-treatment. In Aim II a highly-regarded product engineer work with the company to design a marketable product that may have patentable elements.