RELATE XR, LLC — Department of Health and Human Services STTR Phase I: NIDA

Description

PROJECT SUMMARY / ABSTRACT This Phase I project is a pilot randomized clinical trial designed to show commercial potential for a novel virtual reality intervention in preparation for Phase II development. We propose testing our adjunctive intervention for efficacy on reducing opioid use and increasing abstinence in early recovering opioid use disorder (OUD) persons, with concomitant increases in self-reported and behavioral focus on future outcomes. Impaired future orientation is a hallmark of OUD and other addictions. With recovery attempts usually failing within 6 months of treatment, there is considerable room for improved efficacy. Converging evidence, including our preliminary data, indicates that increasing visualization of the future should improve recovery outcomes. Our pilot testing of the intervention was promising, with n=14 out of N=18 participants remaining abstinent 30 days later; importantly, 10 of the 14 abstainers showed a positive response to the intervention, i.e., 100% of responders remained abstinent—suggesting an efficacy marker. The VR intervention increased future self-identification and delay-of-reward in people recovering from substance use disorder and engaged brain networks governing prospection. Further, the VR effect on delay-of-reward correlated with introspective-executive brain connectivity. Extending prior work on episodic future thinking, we employed a personalized, immersive virtual experience that integrates personal details and maximizes sensory engagement. Our intervention increases connectedness with one’s future through a realistic interaction with Future Selves in diverging futures resulting from different choices. Importantly, we integrate self-discrepancy theory, focusing on the stark contrast between these futures to heighten impact, and we promote engagement by maximizing the novelty and emotional salience of the experience. Participants in early recovery enter a realistic virtual world, are introduced to a time travel narrative, and interact with two digitally age-progressed Future Selves; one after 15 years of ongoing opioid abuse, and the other after 15 years of recovery. Future Selves speak to the participant about their recovery rewards, or losses from returning to habitual drug use, and personal struggles during the journey. Strong emphasis is placed on agency, optimism, and decision-making. After iterative development and tests of feasibility and safety, the paradigm yielded a promising efficacy signal, behavioral change, and brain target engagement. The current proposal will validate this paradigm in an expanded and more homogenous OUD sample to show efficacy and behavioral mechanisms using the same VR paradigm. Aim 1 will test for efficacy on opioid use outcomes (days of use and abstinence) with longitudinal assessments at 30 days. Aim 2 will determine mechanisms by testing for changes in future self-identification, future orientation, and behavioral delay discounting. Successful validation in Phase I will enable transition into a Phase II commercialization application, with the goal of creating a marketable, affordable, user-friendly software product for facilitating better recovery outcomes in clinical settings.PROJECT NARRATIVE The goal of this project is to test a virtual reality experience for commercial application that is designed to improve recovery outcomes by increasing abstinence, identification with the future self, future orientation, and delayed reward preference in individuals recovering from opioid use disorder. By increasing future orientation and delay-of-reward behavior with a precision medicine personalized experience, the intervention is designed to enhance advantageous decision-making and increase positive future outcomes. The results of this study will provide critical data for creating a commercially viable software product for facilitating relapse prevention and improving opioid use disorder recovery outcomes.