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

NCT05995873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-06-22

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Mclean Hospital

    collaborator OTHER

  • MindLight, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2025-11-17
Completion
2025-11-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995873 on ClinicalTrials.gov