PROJECT SUMMARY Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, we propose to develop and evaluate an avatar-led, digital Acceptance and Commitment Therapy (ACT) program called ACT on Vaping for young adult e-cigarette users at all stages of readiness to quit. This program builds upon an intervention framework employed successfully in previous pilot work, with high user satisfaction and very promising rates of biochemically confirmed tobacco abstinence. In the UG3- phase of this study, we will conduct a pilot randomized controlled trial to preliminarily evaluate acceptability and preliminary efficacy of the intervention relative to a brief advice and education control condition. Go/no-go criteria for the UG3 phase include: (a) Completed app development. (b) Completed FDA Q-submission. (c) Completed pilot trial (n=60) showing satisfaction with ACT on Vaping averaging at least 3.5 out of 5; and (d) relative to control, evidence of better outcomes on at least 1 of 3 efficacy endpoints: change in readiness to quit (mean difference in Contemplation Ladder change scores ≥ 1), 24-hour quit attempts (≥ 5% difference), and cotinine-confirmed 30-day point prevalence abstinence from all nicotine/tobacco products at 3 months (≥ 5% difference). If these benchmarks are met, we will proceed to the UH3 phase—a fully-powered, randomized controlled trial (n=1178) of the two interventions, with a primary efficacy outcome of cotinine-confirmed 30-day point prevalence abstinence at 6 months post-randomization. We will also evaluate moderators and mediators of treatment effects. This project is significant: (1) it focuses on a growing population of young adults who vape, (2) e-cigarette users are at risk for developing nicotine dependence and are exposed to toxicants that negatively impact health; (3) standard care tobacco interventions don’t address the unique treatment needs of young adults who vape, (4) ACT has demonstrated better efficacy than standard care approaches for tobacco treatment, and, (5) there is high consumer demand for vaping cessation programs among young adults, as evidenced by 241,000 young adult enrollments to Truth Initiative’s This is Quitting text messaging program between January 2019 and November 2021. It is also innovative: (1) it is the first ACT-based program of any kind for young adult vaping, (2) a digital cessation program using avatars, interactive games, and other multimedia experiences as engagement strategies is substantially different than existing treatments, (3) there are no evidence-based smartphone apps targeting young adult vaping, despite a strong preference for this modality; and, (4) there are no digital programs of any type with demonstrated efficacy for young adult e- cigarette users at varying levels of readiness to quit.

PROJECT NARRATIVE E-cigarette use is increasing in prevalence among young adults, and standard care interventions for tobacco cessation don’t adequately address the needs of this growing population of young adults who vape. A targeted, self-guided digital therapeutic employing a novel treatment approach and designed for young adults at all stages of readiness to quit vaping could improve the accessibility, acceptability, and efficacy of treatment for young adults who use e-cigarettes.