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

测试阿片类药物使用障碍创新疗法的有效性和安全性的项目

基本信息

批准号：
9910942
负责人：
Fredric Schiffer
金额：
$ 22.49万
依托单位：
MINDLIGHT, LLC
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-30 至 2021-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9910942
关键词：
Aftercare Anxiety Bilateral Brain Brain region Cerebral hemisphere Cerebrum Clinical Communication Computers Country Crossover Design Data Development Devices Doctor of Philosophy Double-Blind Method Drug Screening Drug usage Elements Emotional Engineering Epidemic Evaluation Family Forehead Functional Magnetic Resonance Imaging Goals Hair follicle structure Hamilton Rating Scale for Depression Handedness Heroin Dependence Hospitals Intelligence Lateral Lead Legal patent Letters Light Measures Mediating Mental Depression Methods Multicenter Studies Opiate Addiction Opioid Outcome Measure Participant Patients Periodicity Personality Pharmaceutical Preparations Phase Physiological Placebos Procedures Process Psychology Psychotherapy Randomized Relapse Research Peer Review Safety Side Small Business Innovation Research Grant Societies Symptoms Techniques Testing TimeLine Trauma United States Urine Validation Vision Visual Fields Well in self Work active method addiction base clinical application control trial craving design drug craving effective therapy efficacy testing field study improved innovation insight medical schools medication-assisted treatment negative affect novel off-patent opioid epidemic opioid use opioid use disorder personalized approach photobiomodulation placebo controlled study placebo group primary outcome prototype psychologic response societal costs tool weapons

项目摘要

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.

抽象的该项目旨在证明一种治疗阿片成瘾的新疗法是安全且优越的到假比较治疗。希望这种治疗能够极大地帮助对抗阿片类药物流行病正在我国和世界大部分地区肆虐。治疗包括使用 4 分钟的经颅光生物调节，近红外模式，通过超发光 LED 照射到我们大脑半球上方的前额一侧确定（通过专有测试）具有更积极的情绪效价。基于初步数据显示，我们预计该治疗将非常有效地减少药物渴望、焦虑和抑郁，以及减少旧病复发。我的目标是每周提供两次对两组（主动组和假组）进行为期 4 周的治疗，并专门寻找差异对阿片类药物的渴望、焦虑、抑郁和阿片类药物的使用。我们将每周评估患者治疗后3周的安全性和有效性。在 Aim II 中，一位备受推崇的产品工程师与公司合作设计一款可能具有专利元素的适销产品。

项目成果

期刊论文数量（3）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham.

一种新的治疗阿片类药物渴望的方法，单侧经颅光生物调节的效果大小为 0.73。

DOI：
10.3389/fpsyt.2020.00827
发表时间：
2020
期刊：
Frontiers in psychiatry
影响因子：
4.7
作者：
Schiffer,Fredric;Reichmann,William;Flynn,Edward;Hamblin,MichaelR;McCormack,Hannah
通讯作者：
McCormack,Hannah

The physical nature of subjective experience and its interaction with the brain.

主观体验的物理本质及其与大脑的相互作用。