A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham.

Fredric Schiffer,Michael R Hamblin,Edward Flynn,Hannah Mccormack,William Reichmann

doi:10.3389/fpsyt.2020.00827

Abstract

BackgroundOpioid use disorders (OUDs) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (t-PBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP).MethodsWe used 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 1-h weekly sessions. After baseline measures of opioid craving and other psychometrics, subjects received 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 we used two tests to determine which hemisphere was more associated with a negative outlook and cravings and treated that side before the more positive hemisphere. Primary outcome measure was an opioid craving scale (OCS). Secondary outcomes were weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments and at follow-up.ResultsImmediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071. The effect size for the differences between active and sham was 0.73. For the active treatment from before and after treatment the effect size was 1.51 and for the sham, 0.45. The HDRS improved from a baseline of 15.1 to 8.8 (SD 10.3) a week after the active treatment and to 13.3 (SD 12.9) after the sham (p = 0.0071). HARS improved from 14.7 to 8.0 (SD 13.2) after the active treatments and to 14.3 (SD 16.0) after the sham, p = 0.08. Active treatment of the positive hemisphere after the negative hemisphere significantly improved the OCS, but there was no significant difference after the sham treatment. One patient complained of 2 h of abdominal bloating and dropped out; no other adverse effects were observed.DiscussionUnilateral t-PBM to the hemisphere with a more positive hemispheric emotional valence was an effective and safe treatment for opioid cravings as well as for depression and anxiety. Our results also lend support to the underlying premises of DBP.

Highlights

According to the National Institute on Drug Abuse, “The combined healthcare, crime-related, and productivity costs of tobacco, alcohol, and illicit drugs exceed $700 billion a year, but dollars only poorly approximate the devastating human cost of substance use disorders” [1]
We initially enrolled 22 patients whose overall baseline characteristics are described in Table 2 and a more complete description is in the Supplementary Material (SM)
When we compared the active and sham conditions for all remaining 17 patients we found, as shown in Table 3 and Figure 3, a percent decrease in Opioid Craving Scale (OCS) of 51.0% (33.7) for the week following the active treatment and only 15.8% (35.0) for the week following the sham, p = 0.0040, one-sided Wilcoxon test

Summary

Introduction

Drug abusing patients demonstrate mental distress, health complications, loss of productivity, and increased criminality, which are injurious to patients and their families, and to society as a whole. We have obtained preliminary data [5] that a simple, painless, inexpensive, and safe treatment called unilateral transcranial photobiomodulation (tPBM) using nearinfrared light (NIR) may effectively benefit patients with a history of opiate dependence by improving their psychological well-being. The physiological benefits to the brain from tPBM have been the subject of a rich literature of >400 papers on PubMed and several reviews [6,7,8,9,10]. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (tPBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP)

Methods

Results

Conclusion