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Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340622
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : May 25, 2021
Sponsor:
Collaborators:
Mclean Hospital
Harvard Medical School (HMS and HSDM)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
MindLight, LLC

Study Description
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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
Opioid-use Disorder Opioid Dependence Opioid Abuse Device: supra-luminous LED Device: Sham Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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.
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 : November 12, 2019
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Change in Opioid Craving Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: One year ]
    patient reports supported by urine drug screens and a drug hair test at the end of the study


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340622


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
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
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Principal Investigator: Fredric Schiffer, MD MindLight, LLC
Principal Investigator: Martin Teicher, MD, PhD McLean Hospital and Harvard Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MindLight, LLC
ClinicalTrials.gov Identifier: NCT04340622    
Other Study ID Numbers: R43DA050358 ( U.S. NIH Grant/Contract )
1R43DA050358-01 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Without any identifying participant information, study data may be shared at the investigator's discretion.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: upon completion of the study
Access Criteria: Investigators will not share any individual participant identifying data. Each participant will be given a participant number and this number will be shared with the participant's data. All participant data will be shared but without any participant, personal identifying data.

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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:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders