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

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

Last updated 2024-03-26

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

  • Opioid Use Disorder, Moderate
  • Opioid Use
  • Opioid Dependence
  • Opioid Abuse
  • Opiate Dependence
  • Opioid Use, Unspecified

Interventions

DEVICE

unilateral transcranial photobiomodulation

An 810nM LED at 240mW/cm2 is placed at either F3 or F4 for 4 minutes.

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
2024-08-30
Completion
2024-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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