NCT04340622

Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: MindLight, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be healthier, more mature, and less traumatized. Investigators will compare an active and a sham treatment given twice weekly for 4-weeks. Investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.

Detailed description

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 opioid epidemic that is ravaging much of the 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. The investigators will evaluate participants weekly for safety and efficacy for 3-weeks post-treatment. In Aim II a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.

Conditions

• Opioid-use Disorder
• Opioid Dependence
• Opioid Abuse

Interventions

Type	Name	Description
DEVICE	supra-luminous LED	810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.
DEVICE	Sham	Light-emitting diode covered with aluminium foil

Timeline

• Start date: 2019-11-12
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2020-04-09
• Last updated: 2021-05-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study