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Completed
NCT05995873
A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.
Conditions: Opioid Use Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: MindLight, LLC
Location: MindLight, LLC Newton Highlands Massachusetts
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 among actively using participants an active and a sham treatment given either once or twice weekly for 25-weeks at 2 sites. 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.
Eligibility Criteria
Inclusion Criteria:
* Male or non-pregnant females between 18-65 years of age
* Individuals having an opioid use disorder with mild-to-severe symptoms
Exclusion Criteria:
* Individuals who are pregnant,
* Individuals who are psychotic,
* Individuals who are actively suicidal,
* Individuals who are a danger to self or others,
* Individuals who are who have a history of severe psychiatric or neurological disorders or life-threatening medical illness.
* Individuals will be excluded with chronic pain requiring opioid treatment.
* Individuals who are who are breastfeeding,
* Individuals who are adults requiring a legally authorized representative.
Source: ClinicalTrials.gov (NCT05995873). StuddyBuddy aggregates publicly available trial information.