This Project Grant award from the National Institute on Drug Abuse (CFDA 93.279 - Drug Use and Addiction Research Programs) provides $319,278 to Photopharmics, Inc. to evaluate the efficacy of a novel non-pharmacological device called Heterodyned Whole Body Vibration (HWBV) for treating Opioid Use Disorder (OUD).
The key objectives of this project are to: 1) improve the technical aspects of the HWBV device, evaluate physiological indices of anxiety, and implement telemetry to control and monitor the device; 2) evaluate blood catecholamine levels and leukocyte dopamine D2 receptors as potential biomarkers of brain dopamine function and treatment efficacy in drug-free volunteers; and 3) engage with the FDA to create a commercial prototype for de novo device clearance. In a subsequent Phase II, the project will evaluate the effects of HWBV versus sham treatment in a pivotal clinical trial of 160 male and female OUD subjects to support FDA clearance and commercialization of the technology.