Clinical trial NCT04340622: 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
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid Dependence
Opioid Abuse
Lead sponsor: MindLight, LLC
Sponsor class: INDUSTRY
Collaborators: name: Mclean Hospital
name: Harvard Medical School (HMS and HSDM)
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-04-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Opioid Craving Scale
timeFrame: One year
measure: Change in Opioid drug use
timeFrame: One year
Secondary outcomes:
measure: Change in Patient reports of opioid use by TimeLine FollowBack method
timeFrame: One year
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Newton Highlands
country: United States
facility: MindLight, LLC
state: Massachusetts
Study officials:
affiliation: MindLight, LLC
name: Fredric Schiffer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McLean Hospital and Harvard Medical School
name: Martin Teicher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.