A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.
Opioid Use Disorder, Moderate, Opioid Use, Opioid Dependence
About this trial
This is an interventional treatment trial for Opioid Use Disorder, Moderate
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant females between 18-65 years of age Individuals having an opioid use disorder with mild-to-moderately 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
treatment
Active treatment
Half of the participants will receive sham. Treatment will be 2 times a week for 4 weeks, then once a week for 20 weeks and then a followup 1 week later. The sham device is identical to the active device except that it has foil over the LED.
Participants in this group will receive a 4-minute unilateral transcranial photobiomodulation treatment.