Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid-use Disorder, Opioid Dependence, Opioid Abuse

Intervention / Treatment
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* Device: supra-luminous LED
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reduction in opioid cravings and use<br>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<br>* 810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.<br>* Other names: unilateral trancranial photobiomodulation, near-infrared mode;|
| Placebo Comparator: Small reduction in opioid cravings and use<br>Sham condition. | Device: Sham<br>* Light-emitting diode covered with aluminium foil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 
| 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One year |