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

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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.