Novel, On-demand VR for Accessible, Practical, and Engaging therapy (NO VAPE)

Project Summary/Abstract Vaping is an increasing problem in the US, carrying significant health risks. In 2019, 25% of high school students reported past month vaping. One million adolescents and 1.3 million never-smoking adults are now dependent on vaped nicotine. Nicotine vaping is associated with multiple adverse reactions including oral health issues, lung injury, and cardiac, respiratory, and gastrointestinal disorders. Limited vaping cessation interventions have been developed; and current treatments have limited accessibility due to systemic barriers to care, including scarcity of treaters, and high cost. Digital therapeutics (DTx) can be used to reduce these barriers; the current DTx is This Is Quitting (TIQ), a free text messaging application that uses education and behavioral psychology to support vaping cessation. TIQ is the only intervention with proven efficacy for nicotine vaping cessation to date. Embedding CBT content into virtual reality (VR) is a strategy Charles River Analytics employed in a successful NIDA SBIR, Constructed Environments for Successfully Sustaining Abstinence Through Immersive, On-Demand Treatment (CESSATION), developed in partnership with Drs. Corinne Cather and Eden Evins at Massachusetts General Hospital. Here, we propose to develop and test an engaging and immersive VR-based cognitive behavioral therapy (CBT) app focused instead on vaping: Novel, On-demand VR for Accessible, Practical, and Engaging therapy (NO VAPE). NO VAPE allows users to practice CBT skills gained in traditional therapy, and provides accessible, immersive, engaging, and ecologically valid practice, motivating greater intervention adherence and satisfaction, and removing many barriers to care access. Thus, we hypothesize that NO VAPE will enhance vaping cessation outcomes in chronic vapers who want to quit. In Phase I, we will: (1) produce 10 VR-based narratives designed to remain novel and engaging across persistent use, (2) solicit feedback from payors and FDA to ensure positive coverage decisions by payors and meet FDA standards, (3), conduct Human Factors studies to ensure a low-risk application before Phase II. In Phase II, we will: (4) conduct a Clinical Trial to test whether NO VAPE is safe and effective so it can augment or change clinical practice, and (5) prepare to market NO VAPE to potential users. A commercially-available VR-integrated CBT tool for clinicians and patients will improve clinical practice, and make CBT available to consumers directly if they wish to use it on their own, helping more people quit vaping.