Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Status Completed

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

Clinical Trial Details

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

View Details

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	`NCT05049460` - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder	N/A
Recruiting	`NCT05028998` - COVID-19-Related Opioid Treatment Policy Evaluation
Recruiting	`NCT04927143` - Encouraging Abstinence Behavior in a Drug Epidemic	Phase 2
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
Suspended	`NCT02687360` - Imaging the Effects of rTMS on Chronic Pain	N/A
Completed	`NCT04056182` - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment	Phase 2