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

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder; Depression, Anxiety; Craving
• Intervention / Treatment: Device: unilateral transcranial photobiomodulation, near infrared mode; Device: Sham treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton Highlands, Massachusetts, United States, 02461
      • MindLight, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Patients will receive the active treatment.	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.
Sham Comparator: Sham; Patients will receive the sham treatment (the identical LED covered by aluminum foil).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Craving Scale, OCS	A published scale that consists of 3 questions, each rated by the patient from 0 to 9. with 9 indicating severe cravings.	immediately before and after treatments and one week later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale, HDRS	Standard depression rating scale; 0 to 53, a low score is less depressed. 0 to 7 is no depression.	Before each treatment and 1 week later
Hamilton Anxiety Rating Scale, HARS	A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety	Before each treatment and 1 week later
The Positive and Negative Affect Scale, PANAS	Patient rated positive and negative affects from 1 to 5. Five indicates extreme positive or negative affect. Scores for Positive and Negative Affects range from 0 to 25. A higher positive affect score and a lower negative affect score are better.	Before each treatment and 1 week later

Collaborators and Investigators

• Sponsor: MindLight, LLC
• Investigators: Principal Investigator: Fredric Schiffer, MindLight, LLC

Publications and helpful links

Helpful Links

• published paper describing the study

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 22, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: depression; anxiety; opioid use disorder; opioid craving; transcranial photobiomodulation; near infra-red light; dual-brain psychology; cerebral laterality
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Depression; Opioid-Related Disorders
• Other Study ID Numbers: NEIRB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: No personal identifying information of the patients will ever be released, but data for patient numbers will be.
• IPD Sharing Time Frame: Data will become available publication of the study and will be available online if the study is published.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No