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.