Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340622
• Other study ID #: R43DA050358
• Secondary ID: 1R43DA050358-01
• Status: Completed
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: May 2021
• Source: MindLight, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid Dependence
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Device:
• supra-luminous LED
810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.
• Sham
Light-emitting diode covered with aluminium foil

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts
United States	MindLight, LLC	Newton Highlands	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
MindLight, LLC	Harvard Medical School, Mclean Hospital, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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