SBIR-STTR Award

Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders (R41/R42 - Clinical Trial Optional)
Award last edited on: 12/29/2023

Sponsored Program
STTR
Awarding Agency
NIH : NIDA
Total Award Amount
$218,097
Award Phase
1
Solicitation Topic Code
279
Principal Investigator
Erik Muendel

Company Information

Brightline Interactive LLC

21745 Red Rum Drive Suite #242
Ashburn, VA 20147

Research Institution

George Mason University

Phase I

Contract Number: 1R41DA050225-01
Start Date: 8/15/2020    Completed: 8/14/2021
Phase I year
2020
Phase I Amount
$218,097
R&R Other Project Information 7. Project Summary/Abstract Neurobiological changes caused by addiction impair behavioral control and increase relapse risk (Volkow, Koob, & McLellan, 2016), substantiating the need for long-term care coordination and recovery engagement for individuals with Substance Use Disorders (SUD) (Humphreys, Malenka, Knutson, & MacCoun, 2017). Because addiction creates stress and reward system dysregulation impairing emotional regulation and executive functioning capacities when experiencing intense craving (Volkow, Koob & McLellan, 2016), traditional didactic relapse prevention strategies may have limited efficacy for those in early recovery when they transition back to their natural communitiesÂ’ post-discharge from treatment, where they will be exposed to SUD-related stimuli. New recovery support models that detect implicit cue-induced neurophysiological dysregulation and restore real-time regulatory capacity to decrease relapse risk are of clinical significance. ?This feasibility Phase I study will use Virtual Reality (VR) technology to 1) simulate a patient-specific drug cue-triggering experience (VR_drug) to calibrate a personalized neurophysiological relapse risk set-point, captured in-session using fNIRS (?Functional Near-Infrared Spectroscopy?) sensors, a portable alternative to fMRI which will be integrated into the VR HMD (Head Mounted Display),? and physiological sensors (smartwatch Empatica E4) worn during the VR_drug scenario ?(Aim 1); ?and 2) simulate a recovery-regulation experience (VR_recovery) using patient-specific virtually-generated sober-supportive relationships, recovery-enhanced environmental conditions, and recovery-associated sensory cues, to calibrate a recovery-regulated neurophysiological set-point, captured by the same in-session neurophysiological sensors systems ?(Aim 2)?. If successful, in Phase II, a mobile recovery support system product will be developed to help individuals in SUD recovery modulate real-time craving by monitoring their personalized neurophysiological relapse risk and activating their recovery-regulation intervention (VR_recovery) to alter urge reactivity in real-time. This type of mobile intervention that is immediately available to individuals in recovery as they leave treatment institutions and transition back into their natural communities may help manage in-the-moment drug urges in ways that allow engagement in other recovery-related activities (e.g., calling a sponsor, getting to a meeting), decreasing real-time relapse risk (Matto,& Seshaiyer, 2018; Matto, 2015; Matto, et al, 2014).

Public Health Relevance Statement:
R&R Other Project Information 8. Project Narrative Addiction is a self-regulation disorder where chronic exposure to and compulsive consumption of the drug creates dysregulation in the reward, stress and executive functioning regions of the brain, intensifying emotional reactivity and impairing cognitive and behavioral control (Volkow, Koob, & McLellan, 2016). This study seeks to examine the utility of using Virtual Reality (VR) simulations to calibrate person-specific neurophysiological relapse-risk and recovery regulation set-points. Results may lead to the development of a non-pharmacological mobile recovery support system to help individuals in SUD recovery manage implicit craving reactivity in ways that reduce relapse risk.

Project Terms:
addiction; Address; Adult; Area; Artificial Intelligence; Back; base; Behavior Control; Behavioral; behavioral impairment; Brain; Brain region; care coordination; Chronic; Clinical Trials; clinically significant; Cocaine; Cognitive; cognitive control; Communities; conditioning; Conscious; Consumption; craving; cue reactivity; Cues; Data; Databases; Development; Disease; disorder later incidence prevention; Drug Addiction; DSM-V; emotion regulation; Emotional; Euphoria; Evidence based treatment; executive function; experience; Exposure to; Feedback; Feeds; Functional Magnetic Resonance Imaging; Goals; head mounted display; Image; Imagery; Impaired cognition; Impairment; implicit memory; Individual; Informal Social Control; Institution; Intelligence; Intervention; Interview; Lead; Long-Term Care; meetings; Modeling; Monitor; Motivation; Near-Infrared Spectroscopy; Neurobiology; neurophysiology; Patients; Persons; Pharmaceutical Preparations; Phase; phase 1 study; Physiological; Pilot Projects; Play; portability; Prevention strategy; profiles in patients; Protocols documentation; prototype; Recovery; Regulation; relapse risk; Research; response; Rewards; Risk; Role; sensor; Sensory; simulation; smart watch; sobriety; Stimulus; Stress; Structure; Substance Use Disorder; Support System; System; Technology; Testing; Time; tool; virtual; virtual reality; virtual reality simulation

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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