NCT05995873

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 26, 2024

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

July 14, 2023

Last Update Submit

March 24, 2024

Conditions

Opioid Use Disorder, ModerateOpioid UseOpioid DependenceOpioid AbuseOpiate DependenceOpioid Use, Unspecified

Outcome Measures

Primary Outcomes (1)

  • percent of participants that achieve abstenense

    we will test for use with urine and hair 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.

Device: unilateral transcranial photobiomodulation

Active treatment

EXPERIMENTAL

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

Device: unilateral transcranial photobiomodulation

Interventions

unilateral transcranial photobiomodulationDEVICE

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

Active treatmenttreatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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-moderately 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MindLight, LLC

Newton Highlands, Massachusetts, 02461, United States

RECRUITING

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: 34447323BACKGROUND

Related Links

MeSH Terms

Conditions

Opioid-Related DisordersLymphoma, Follicular

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Fredric Schiffer, MD

CONTACT

781-405-8800fred.schiffermd@gmail.com

Nawar Wood, BA

CONTACT

617-860-9002nawar.wood@gmail.com

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.
Purpose
TREATMENT
Intervention Model
PARALLEL
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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 16, 2023

Study Start

January 22, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

March 26, 2024

Record last verified: 2023-08

Locations

US(1)