Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Completed · Not applicable · Has a placebo group

Conditions studied: Opioid-use Disorder, Opioid Dependence, Opioid Abuse

In brief

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.

Key facts

Study ID

NCT04340622

Run by

MindLight, LLC

People needed

39

Starts

2019-11-12

Expected to finish

2021-03-30

Last updated by the study team

2021-05-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States
• MindLight, LLC — Newton Highlands, Massachusetts, United States

Full record on ClinicalTrials.gov

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