An interventional study of supra-luminous LED and Sham in Opioid-use Disorder, Opioid Dependence and Opioid Abuse, sponsored by MindLight, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by MindLight, LLC · Not applicable, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 39 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →MindLight, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Sham condition.
Device: Sham
810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.
Also known as: unilateral trancranial photobiomodulation, near-infrared mode
Light-emitting diode covered with aluminium foil
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.
Time frame: 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.
Time frame: One year
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
Time frame: One year
Plan to share: Yes — Without any identifying participant information, study data may be shared at the investigator's discretion.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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