Transcranial Photobiomodulation for the Treatment of Opioid Cravings

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid-use Disorder, Depression, Anxiety, Craving

Intervention / Treatment
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* Device: unilateral transcranial photobiomodulation, near infrared mode
* Device: Sham treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Patients will receive the active treatment. | Device: unilateral transcranial photobiomodulation, near infrared mode<br>* 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.<br>|
| Sham Comparator: Sham<br>Patients will receive the sham treatment (the identical LED covered by aluminum foil). | Device: Sham treatment<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid craving, opioid use disorder, depression, anxiety, transcranial photobiomodulation, near infra-red light, dual-brain psychology, cerebral laterality