Transcranial Photobiomodulation for the Treatment of Opioid Cravings
Condition: Opioid-use Disorder; Depression, Anxiety; Craving
MeSH terms: Opioid-Related Disorders; Depression
Study type: Interventional

Summary: 
      The investigators wish to test the hypothesis that transcranial photobiomodulation (tPBM)
      (i.e., 4-minutes of 810nm near-infrared light at 250 mW/cm2 by LED to the forehead at F3 or
      F4 versus an indistinguishable placebo treatment) can safely reduce opioid craving in
      individuals with opioid dependence in a within-patient study.
    

Detailed description: 
      Opioid use disorders (OUD) are an epidemic causing catastrophic consequences to individuals,
      families, and society despite treatments including psychotherapy, substitution therapy or
      receptor blockers, and psychoeducation. The investigators have developed a novel treatment
      that combines transcranial photobiomodulation (t-PBM) and Schiffer's Dual Brain Psychology
      (DBP)

      The investigators will use a randomized, double-blind, placebo-controlled protocol in which
      22 patients with significant opioid cravings and a history of recent or current OUD attended
      three one-hour weekly sessions. After baseline measures of opioid craving, and other
      psychometrics, subjects will receive two unilateral t-PBM applications (810 nm CW LED, 250
      mW/cm2, 60 J/cm2, 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment,
      the investigators will use 2 tests to determine which hemisphere is more associated with a
      negative outlook and cravings and will treat that side before the more positive hemisphere.
      The primary outcome measure will be an opioid craving scale (OCS). plus weekly Hamilton
      Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments. Patients will be
      closely monitored for any possible adverse side-effects from the treatment.
    

Intervention name(s): unilateral transcranial photobiomodulation, near infrared mode; Sham treatment
Intervention type(s): Device; Device
Intervention description(s): The investigators are applying a supra luminous LED at 810 nm and 250 mW/cm2 to the forehead of the participant at F3 and F4.; The sham treatment is identical to the active treatment except that the sham treatment has a piece of aluminum foil covering the led so that the participant will experience warmth but receive no photons.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will come to the lab on 3 consecutive weekly visits. On the first, they go through the consent process and if signed, will have a clinical interview and ROS then be given baseline measures and then treated with transcranial photobiomodulation, following which they will undergo post-treatment measures. The treatment the first week will be randomized to active or sham and the second week they will receive the opposite treatment. The third week will be a follow-up of the second treatment.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid craving; opioid use disorder; depression; anxiety; transcranial photobiomodulation; near infra-red light; dual-brain psychology; cerebral laterality