Transcranial Photobiomodulation for the Treatment of Opioid Cravings

MindLight

Status: Completed

Conditions: Opioid-use Disorder; Craving; Depression, Anxiety

Treatments: Device: Sham treatment; Device: unilateral transcranial photobiomodulation, near infrared mode

Study type: Interventional

Funder types: Industry

Identifiers

NCT04417738

NEIRB001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients complain of opioid cravings
• between the ages of 18 and 65.
• meet criteria for a history of opioid dependence by DSM V.

Exclusion criteria

• a past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
• a history of violent behavior
• a history of a past suicide attempt
• a history of current suicidal ideation
• a history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), pregnancy,
• any current acute or chronic medical condition that might confound the study.
• Any patient judged by an investigator to have an impaired decision-making capacity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

22 participants in 2 patient groups

Active

Active Comparator group

Description:

Patients will receive the active treatment.

Treatment:

Device: unilateral transcranial photobiomodulation, near infrared mode

Sham

Sham Comparator group

Description:

Patients will receive the sham treatment (the identical LED covered by aluminum foil).

Treatment:

Device: Sham treatment