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Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

NCT04340622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-05-25

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 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.

Conditions

  • Opioid-use Disorder
  • Opioid Dependence
  • Opioid Abuse

Interventions

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

Sponsors & Collaborators

  • Mclean Hospital

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • MindLight, LLC

    lead INDUSTRY

Principal Investigators

  • Fredric Schiffer, MD · MindLight, LLC

  • Martin Teicher, MD, PhD · McLean Hospital and Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2021-03-30
Completion
2021-03-30
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 NCT04340622 on ClinicalTrials.gov