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COMPLETED
NCT05995873
NA

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

Sponsor: MindLight, LLC

View on ClinicalTrials.gov

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 among actively using participants an active and a sham treatment given either once or twice weekly for 25-weeks at 2 sites. 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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-01-22

Completion Date

2025-11-17

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

OTHER

Sham unilateral transcranial photobiomodulation

The same device as in the active condition except that it has a metalic stickie over the LED so that the particpant feels warmth but receives no photons.

DEVICE

transcranial photobiomodulation at 810 nm at 250 mW/cm2 for 4 minutes

transcrainal photobiomodulation at 810 nm at 250 mW/cm2 for 4 minutes at F3 or F4

Locations (1)

MindLight, LLC

Newton Highlands, Massachusetts, United States