Modular Virtual Reality Therapeutic for Opioid and Stimulant Use Disorders

PROJECT SUMMARY Opioid and/or Stimulant Use Disorders (OUD/StUD) are chronic, recurring conditions that if left untreated, pose a significant and ongoing public health and safety threat, with costs associated with OUD alone in the US exceeding one trillion dollars annually. Virtual Reality Cue Exposure (VRCE) employs safe and controlled

repeated exposure to a variety of substance use cues and environments designed to induce craving within the

virtual space. This can be done in a way that is not feasible “in vivo” due to health and safety concerns, filling a persistent gap in current treatment approaches for the non-pharmacological treatment of OUD/StUD. While in the virtual environment, the patient will habituate to the substance use cues and work with a therapist to learn

coping skills for tolerating craving while not ingesting substances, weakening the conditioned association between substance use cues and actual substance use. The HelixVR digital therapeutic is a modular VRCE based software that allows for simulations to be tailored to each patient and is designed for use as an

adjunctive treatment for OUD/StUD under the supervision of a licensed master’s level behavioral health provider. Phase I work to be completed will include refinement of the user interface and increasing the number of features offered within the software. In Phase I we will conduct a pilot effectiveness study to investigate the

impact of HelixVR on substance craving, substance use and overall quality of life. Participants (n = 50) will be randomized to receive 4 sessions of HelixVR or another active VR based intervention at an outpatient substance use treatment organization. Our Phase I hypothesis is that the addition of the fully immersive and tailored

HelixVR intervention into routine treatment will be associated with increased treatment completion, decreased substance craving and decreased substance use relative to a non-tailored less immersive VR intervention. This work will be followed by a Phase II study to expand the number of cues and environments available while

conducting a muti-site RCT (n = 200) to further evaluate the effectiveness of HelixVR. Our Phase II hypothesis is that the use of the HelixVR digital therapeutic will result in decreased craving and substance use, as well as decreased return to use, emergency healthcare usage, involvement with child welfare and involvement with the

criminal justice system. We anticipate that these changes will be maintained for 12 months post treatment. We will continuously adjust our business plan, software content and clinical workflow integration protocols based on feedback from our target customer demographics. Our long-term goal is to offer a high impact digital

therapeutic which is easily integrated into clinicians’ normal workflow, decreasing the significant social and public health impact of OUD/StUD.