Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04340622
Study type Interventional
Source MindLight, LLC
Contact
Status Completed
Phase N/A
Start date November 12, 2019
Completion date March 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Completed NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Active, not recruiting NCT04650386 - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Enrolling by invitation NCT04991974 - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine Phase 2/Phase 3
Completed NCT04122755 - Single Ascending Dose Study of ALA-1000 Phase 1
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Recruiting NCT05049460 - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder N/A
Recruiting NCT05028998 - COVID-19-Related Opioid Treatment Policy Evaluation
Completed NCT05047627 - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder N/A
Active, not recruiting NCT04129580 - reSET-O RCT (Randomized Controlled Trial) N/A
Recruiting NCT03923374 - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed NCT04464421 - SMART Effectiveness Trial N/A
Completed NCT04056182 - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment Phase 2
Suspended NCT02687360 - Imaging the Effects of rTMS on Chronic Pain N/A