NCT04417738

Transcranial Photobiomodulation for the Treatment of Opioid Cravings

Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: MindLight, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-use Disorder
• Depression, Anxiety
• Craving

Interventions

Type	Name	Description
DEVICE	unilateral transcranial photobiomodulation, near infrared mode	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.
DEVICE	Sham treatment	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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-11-15
• Completion: 2019-11-15
• First posted: 2020-06-05
• Last updated: 2021-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study