Clinical Research Directory

Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors

Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults. With limited information on the long-term effects of vaping products, health information about vaping has been somewhat unclear in regards to associated health risks. Teens and young adults may be reluctant to disclose their use of vaping products to parents or health providers and instead turn to social media to share and seek out information regarding vaping risks and cessation supports. Thus, our current proposal outlines the use of social media to identify teens and young adults socially networking about vaping, the use of an online chatbot screen to evaluate individual cessation support needs, and the use of a digital intervention system to support vaping cessation. The mobile intervention used in this study is based on a widely-used evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been adapted for vaping and young adults to include an in-app chatbot to guide users to tailored content and to motivate and encourage their cessation efforts. We aim to integrate our social media recruitment and online screening approach to connect individuals with this mobile app intervention, and will conduct a randomized controlled trial to evaluate user engagement with and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens and young adults.

Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency

Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS "significantly less addictive and appealing to youth." However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the "nicotine flux", can be regulated and, importantly, predicted based on a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective framework for regulating ENDS. At the American University of Beirut, the investigators will assess the relationship between nicotine flux, form, and subjective effects. Participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.

Kick-Nic! Youth Quit Vaping App

High school and middle school students who want to quit vaping will be randomized to receive the Kick-Nic! app or a control NCI website to determine the efficacy of the app for vaping cessation. Participants will be screened for eligibility, then go through an 8 week treatment period where they will be given access to use the Kick-Nic! app or referred to the NCI Quit Vaping website. This will be followed by 1.5, 3, 4.5 and then 6 month follow up visits. Qualitative interviews with participants and school staff will also be conducted to obtain feedback on the app and best ways to implement/disseminate the app. Abstinence rates will be assessed biweekly during treatment including at end of treatment (EOT), and then at 1.5, 3, 4.5 and then 6 months follow ups (FU). Biochemical verification (salivary cotinine \< 30 ng.ml) of self-reports of abstinence will be conducted at EOT and 6-month FU.

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.

Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

Pilot Study of the YES-CAN! Program to Prevent Youth Nicotine Vaping

The goal of this pilot study is to determine the feasibility of a randomized trial of the YES-CAN! (Youth Engaged Strategies to Change Adolescent Norms) program to prevent nicotine vaping among adolescents. The program integrates the following evidence-based strategies: youth-adult collaboration; youth-developed narrative videos to convey health messages; peer leaders as change agents; and sustained implementation to change the normative environment. Two middle/high school communities will receive the YES-CAN! intervention. In each school community, a trained teacher will deliver a credit-earning middle or high school class to 25-30 middle or high school students, who will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among current users. Videos will use a narrative approach and integrate known determinants of vaping. Middle or high school students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. In 6-8 sessions, middle or high school students will deliver their videos to all students in the associated middle school. A text messaging or other media component will reinforce and boost the effectiveness of the classroom sessions. Aims for this pilot/feasibility study are: 1. To determine the feasibility and acceptability of implementing the YES-CAN! program 2. To determine the feasibility and acceptability of the research protocols that will be used in a future efficacy trial