Transcranial Photobiomodulation for the Treatment of Opioid Cravings

MindLight, LLC22 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Opioid-use Disorder Depression, Anxiety Craving

Interventions

unilateral transcranial photobiomodulation, near infrared modeDEVICE

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 treatmentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

MindLight, LLC

Newton Highlands, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: immediately before and after treatments and one week later

Secondary Outcomes

Hamilton Depression Rating Scale, HDRS

Standard depression rating scale; 0 to 53, a low score is less depressed. 0 to 7 is no depression.

Time frame: 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

Time frame: 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.

Time frame: Before each treatment and 1 week later

Data from ClinicalTrials.gov

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