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Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Primary Purpose

Opioid-use Disorder, Opioid Dependence, Opioid Abuse

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

supra-luminous LED

Sham

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

McLean Hospital
MindLight, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Reduction in opioid cravings and use

Small reduction in opioid cravings and use

Arm Description

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.

Sham condition.

Outcomes

Primary Outcome Measures

Change in Opioid Craving Scale

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.

Change in Opioid drug use

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

Change in Patient reports of opioid use by TimeLine FollowBack method

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

Full Information

NCT ID

NCT04340622

First Posted

September 25, 2019

Last Updated

May 22, 2021

Sponsor

MindLight, LLC

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04340622

Brief Title

Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Official Title

A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

November 12, 2019 (Actual)

Primary Completion Date

March 30, 2021 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MindLight, LLC

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder, Opioid Dependence, Opioid Abuse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reduction in opioid cravings and use

Arm Type

Active Comparator

Arm Description

Arm Title

Small reduction in opioid cravings and use

Arm Type

Placebo Comparator

Arm Description

Sham condition.

Intervention Type

Device

Intervention Name(s)

supra-luminous LED

Other Intervention Name(s)

unilateral trancranial photobiomodulation, near-infrared mode

Intervention Description

810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

Light-emitting diode covered with aluminium foil

Primary Outcome Measure Information:

Title

Change in Opioid Craving Scale

Description

Time Frame

One year

Title

Change in Opioid drug use

Description

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

Time Frame

One year

Secondary Outcome Measure Information:

Title

Change in Patient reports of opioid use by TimeLine FollowBack method

Description

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

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fredric Schiffer, MD

Organizational Affiliation

MindLight, LLC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Teicher, MD, PhD

Organizational Affiliation

McLean Hospital and Harvard Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

Facility Name

MindLight, LLC

City

Newton Highlands

State/Province

Massachusetts

ZIP/Postal Code

02461

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Without any identifying participant information, study data may be shared at the investigator's discretion.

IPD Sharing Time Frame

upon completion of the study

IPD Sharing 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.

Citations:

PubMed Identifier

34447323

Citation

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.

Results Reference

derived

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Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

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