Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

MindLight

Status: Completed

Conditions: Opioid-use Disorder; Opioid Abuse; Opioid Dependence

Treatments: Device: supra-luminous LED; Device: Sham

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04340622

1R43DA050358-01 (U.S. NIH Grant/Contract)

R43DA050358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

Reduction in opioid cravings and use

Active Comparator group

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.

Treatment:

Device: supra-luminous LED

Small reduction in opioid cravings and use

Placebo Comparator group

Description:

Sham condition.

Treatment:

Device: Sham