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

NCT05995873 | Completed DMC FDA Device

• 1 other identifier: R44DA050358
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Timeline Follow Back participant reports

  TLFB supported by urine drug test

  up to 26 weeks

Secondary Outcomes (1)

• Overall clinical status

  at the end of the study

Study Arms (2)

treatment

SHAM COMPARATOR

Half of the participants will receive sham. Treatment will be 2 times a week for 4 weeks, then once a week for 20 weeks and then a followup 1 week later. The sham device is identical to the active device except that it has foil over the LED.

Other: Sham unilateral transcranial photobiomodulation

Active treatment

EXPERIMENTAL

Participants in this group will receive a 4-minute unilateral transcranial photobiomodulation treatment.

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

Interventions

Sham unilateral transcranial photobiomodulation OTHER

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.

Also known as: sham device

treatment

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

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

Active treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant females between 18-65 years of age
• Individuals having an opioid use disorder with mild-to-severe symptoms

You may not qualify if:

• Individuals who are pregnant,
• Individuals who are psychotic,
• Individuals who are actively suicidal,
• Individuals who are a danger to self or others,
• Individuals who are who have a history of severe psychiatric or neurological disorders or life-threatening medical illness.
• Individuals will be excluded with chronic pain requiring opioid treatment.
• Individuals who are who are breastfeeding,
• Individuals who are adults requiring a legally authorized representative.

Sponsors & Collaborators

• MindLight, LLC: lead
• Mclean Hospital: collaborator

Study Sites (1)

MindLight, LLC

Newton Highlands, Massachusetts, 02461, United States

Location

Related Publications (1)

• Schiffer F, Khan A, Bolger E, Flynn E, Seltzer WP, Teicher MH. An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation. Front Psychiatry. 2021 Aug 10;12:713686. doi: 10.3389/fpsyt.2021.713686. eCollection 2021.

  PMID: 34447323 BACKGROUND

Related Links

• Article: An Effective and Safe Novel Treatment of Opioid Use Disorder

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Only the treater knows whether the participant receives the sham or active treatment. We have an active transcranial photobiomodulation device and a sham device that looks identically and delivers the same heat but no photons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 130 participants will be treated with unilateral transcranial photobiomodulation to their brain hemisphere with a more positive emotional valence. Half will receive sham and half active. Treatment will be 2 times a week for 4 weeks, then once a week for 20 weeks and then a followup 1 week later. The study will be half at MindLight, LLC and half at McLean Hospital.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 16, 2023
• Study Start: January 22, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)