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

点击翻译按钮获取中文摘要

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.