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

Nicotine Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994209
• Other study ID #: 1R34DA054725-01A1
• Secondary ID: R34DA054725
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2024
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Patricia Cavazos-Rehg, PhD
• Phone: 314-362-2152
• Email: pcavazos[@]wust.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 189
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• US Resident

• English Speaking

• Have daily access to a smartphone

• Current vaping product user (P30D)

• Identified as socially networking about a desire to quit vaping and/or experiencing negative health outcomes due to vaping

• Vaping product user only (i.e., not using vaping as a means to support combustible smoking cessation)

Related Conditions & MeSH terms

• Nicotine Use Disorder
• Tobacco Use Disorder

Intervention

Device:
• quitSTART Mobile Application
Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.

Behavioral:
• Chatbot Feature in quitSTART Mobile Application
In-App chatbot feature emedded into quitSTART mobile application to motivate vaping cessation and support app navigation.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Drug Abuse (NIDA), The University of Texas Health Science Center, Houston, University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaping cessation	Vaping cessation as assessed by 7 day self-reported vaping abstinence at follow-up. Timeline follow back procedures will be used to establish abstinence or if participants lapsed (their first instance of vaping post quit) or relapsed (vaped on 7 consecutive days) at each follow up time point.	Baseline, 6 weeks, 3 months
Secondary	Nicotine dependence	Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).	Baseline, 6 weeks, 3 months
Secondary	Risk perception related to vaping	Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020. "How harmful, if at all, do you think vaping/using an e-cigarette is to a user's health?" (general) and "Imagine you vaped/used e-cigarettes daily for the next 10 years and used no other tobacco product. How harmful do you think this vaping would be to your health?" (conditional), both using a five-point response scale (not at all-extremely harmful).	Baseline, 6 weeks, 3 months
Secondary	Intervention engagement	Data automatically captured within the chatbot, and app platform will be used to calculate a composite measure of engagement for those randomized to each of these intervention components and will be examined as a predictor of outcomes. We will use a modified version of an app Engagement Index (EI).	Baseline, 6 weeks, 3 months