Clinical Research

Phase 1 Clinical Study: Reduction of Cravings in Opioid Use Disorder 

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Dr. Schiffer and his colleagues, supported by an NIH SBIR Phase 1 grant, conducted a sham-controlled clinical research study to evaluate unilateral transcranial photobiomodulation (tPBM) for the reduction of cravings in people with Opioid Use Disorder (OUD). The study enrolled 39 participants with active opioid cravings at two study sites. Nineteen study participants received active treatment and the other participants received a sham control twice per week. The active treatment consisted of an application of an LED light to the left or right side of the forehead. The primary outcome measured in the study was changes in pre-treatment cravings as reported on the opioid craving scale (OCS). The active group had a highly statistically significant result compared to the sham group, p< 0.0001, with an effect size of 1.5 at the last follow-up visit. No adverse effects were reported. The results of the study were reported in Frontiers in Psychiatry in August 2021. The publication can be found here. Following the results of this study, the FDA granted unilateral tPBM a Breakthrough Designation status. 

 

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Phase 2 Clinical Study: Reduction of Use in Opioid Use Disorder

(Currently Recruiting Study Participants) 

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Dr. Schiffer and his colleagues are now conducting a Phase 2 clinical study, supported by an NIH SBIR Phase 2 grant. They are evaluating unilateral transcranial photobiomodulation (tPBM) for the reduction of opioid use in Opioid Use Disorder (OUD). The study is recruiting at two sites in Massachusetts. More information about recruitment for the study can be found at the Clinical Connection website. ​

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Relevant Publications

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• Schiffer F, Khan A, Bolger E, Flynn E, Seltzer WP, Teicher MH. An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation. Front Psychiatry. 2021;12:713686. Published 2021 Aug 10. doi:10.3389/fpsyt.2021.713686

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• Schiffer F. Dual-Brain Psychology: A novel theory and treatment based on cerebral laterality and psychopathology. Front Psychol. 2022;13:986374. Published 2022 Oct 19. doi:10.3389/fpsyg.2022.986374