Research and Innovation to Stop E-cigarette/Vaping in Young Adults — (RISE)  

Nicotine Dependence Clinical Trial

Official title: Young Adult Vaping Cessation: A Randomized Trial Examining Phone Coaching, Text-based Digital Intervention, and Nicotine Replacement Therapy

Status Recruiting

Clinical Trial Summary

The aim of this study is to test intervention components to help young adults quit vaping. A 2x2 factorial design will be used where all participants receive quitline-delivered behavioral phone counseling, and components to be tested are a digital intervention (with text and online cessation support) and nicotine replacement therapy (NRT).

The research questions and hypotheses for this study are:

1. Which components and combinations of intervention yield the greatest success rates for exclusive vaping cessation among young adult exclusive e-cigarette users? H1: The complete condition (NRT + digital) will yield significantly higher rates of cessation compared to the control condition (quitline only).

2. Does 8 weeks of nicotine replacement therapy (NRT) improve initial cessation outcomes relative to no NRT.

H2: Providing NRT will yield significantly higher quit rates compared to the No NRT condition.

3. Do tailored text-messages and online support during cessation improve initial cessation outcomes relative to no digital content? Are young adult vapers engaged with and satisfied with digital cessation tools? H3: Digital support will yield significantly higher quit rates compared to no digital support.

H4: Higher engagement in digital content will be associated with higher cessation success rates.

Clinical Trial Description

The investigators will recruit a national, nonprobability sample of young adults (18-24 year olds) who vape nicotine. All study components will be delivered by phone, mail, online, and mobile device. All participants will receive up to 2 coaching calls and will be randomized to one of four groups: no NRT, no Digital; Digital, no NRT; NRT, no Digital; or NRT and Digital.

Participants (final sample size n = 504) must complete one coaching call to be enrolled in the study. The two coaching calls (approximately 10-20 minutes each) focus on 5 "keys" for quitting: setting a quit date, conquering urges, managing physical withdrawal symptoms (or addressing nicotine replacement needs for the NRT groups), vape-proofing environment, and social supports.

In this real-world trial, coaches will be trained to assess vaping use and dose NRT taking into account use frequency, nicotine level, and participant preference, leveraging quitline standard protocols. Participants may be sent up to 8 weeks (patch, gum, and or lozenge) of product in two shipments. Combination NRT (patch plus gum or lozenge) may be offered.

The digital cessation content includes a text messaging program with links to online education and support materials. The text program will be tailored to a participant's quit stage, and include education, tips, motivational messages, and assessment questions yielding tailored content. The online content (brief videos, audio podcasts, quizzes, etc) can be viewed in small segments via texted links. Participants can also engage with the online content by navigating through lessons or suggested content. ;

Related Conditions & MeSH terms

• E-Cig Use
• Nicotine Dependence
• Tobacco Use Disorder

• NCT number: NCT04974580
• Study type: Interventional
• Source: Ohio State University
• Contact: Elizabeth Hustead
• Phone: 614-688-0345
• Email: hustead.7@osu.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: July 5, 2021
• Completion date: June 30, 2023