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Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Sponsor
MindLight, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04340622
Collaborator
Mclean Hospital (Other), Harvard Medical School (HMS and HSDM) (Other), National Institute on Drug Abuse (NIDA) (NIH)
39
Enrollment
2
Locations
2
Arms
16.6
Actual Duration (Months)
19.5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: supra-luminous LED
  • Device: Sham
 N/A

Detailed Description

This project is to demonstrate that a novel treatment for opiate addiction is safe and far superior to a sham comparison treatment. The treatment is hoped to significantly aid in the battle against the opioid epidemic that is ravaging much of the country and the world. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near infra-red mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that we determine (through a proprietary test) to have a more positive emotional valence. Based on preliminary data, we anticipate that the treatment will be very effective in reducing drug cravings, anxiety, and depression as well as in reducing relapses. Aim I will offer twice-weekly treatments to two groups, active and sham, for 4-weeks and will look specifically for differences in opioid cravings, anxiety, depression, and opioid use. The investigators will evaluate participants weekly for safety and efficacy for 3-weeks post-treatment. In Aim II a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
20 participants will receive twice a week active treatment for 4-weeks of a 4-minute near-infrared light treatment through the forehead to a brain hemisphere and 20 will receive a sham treatment.20 participants will receive twice a week active treatment for 4-weeks of a 4-minute near-infrared light treatment through the forehead to a brain hemisphere and 20 will receive a sham treatment.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The sham is created by putting a piece of aluminum foil over the light-emitting diode. It will be placed there or not placed there by a 3rd party so that neither the participant nor the outcomes assessor will know the condition of the study.
Primary Purpose:
Treatment
Official Title:
A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
Actual Study Start Date :
Nov 12, 2019
Actual Primary Completion Date :
Mar 30, 2021
Actual Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Reduction in opioid cravings and use

These participants will receive twice-weekly transcranial photobiomodulation with and 810 nm LED for 4 min for a delivery to the brain of 2.1 J/cm2. The treatment will last 4 weeks. We anticipate a 60% reduction in opioid cravings in this group. We anticipate a reduction of at least 1.6 days of use per week on average.

Device: supra-luminous LED
810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.
Other Names:
  • unilateral trancranial photobiomodulation, near-infrared mode

    		•
    Placebo Comparator: Small reduction in opioid cravings and use

    Sham condition.

    Device: Sham
    Light-emitting diode covered with aluminium foil

    Outcome Measures

    Primary Outcome Measures

    1. Change in Opioid Craving Scale [One year]

      a published 3 question scale of opioid cravings. Each question asks the patient to rate his opioid cravings at the present time from 0 (none) to 9 (extreme). We use the average of the scores of the 3 questions. A low score is best.

    2. Change in Opioid drug use [One year]

      TimeLine FollowBack method, measures the daily amount of opioid drug use (mg's of pills or grams used) for the period between observations.

    Secondary Outcome Measures

    1. Change in Patient reports of opioid use by TimeLine FollowBack method [One year]

      patient reports supported by urine drug screens and a drug hair test at the end of the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • all patients must between the ages of 18 and 70

    • meet criterion for a history of Opioid Use Disorder (OUD) on a Diagnostic Interview.

    • have opioid cravings

    • Enrollment will be made without regard to gender or ethnicity.

    • Patients who are receiving treatment for OUD or other psychiatric disorders, either psychological or pharmacological treatments, may continue their treatment during the time of the study but will be asked to try not to alter their treatment from the onset of the experiment until its conclusion. The statistical analysis will include covariates for doses of buprenorphine and methadone and use of non-prescribed opioids

    Exclusion Criteria:

    • past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)

    • history of violent behavior

    • history of a past suicide gesture or attempt, a history of current suicidal ideation, *history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), *pregnancy

    • current acute or chronic medical condition requiring a medication that has psychological side-effects.

    • impaired decision-making capacity in the judgment of the investigators.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 McLean Hospital Belmont Massachusetts United States 02478
    2 MindLight, LLC Newton Highlands Massachusetts United States 02461

    Sponsors and Collaborators

    • MindLight, LLC
    • Mclean Hospital
    • Harvard Medical School (HMS and HSDM)
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Fredric Schiffer, MD, MindLight, LLC
    • Principal Investigator: Martin Teicher, MD, PhD, McLean Hospital and Harvard Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MindLight, LLC
    ClinicalTrials.gov Identifier:
    NCT04340622
    Other Study ID Numbers:
    • R43DA050358
    • 1R43DA050358-01
    First Posted:
    Apr 9, 2020
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Opioid-Related Disorders

    Study Results

    No Results Posted as of May 25, 2021