Research and Innovation to Stop E-cigarette/Vaping in Young Adults

Phase 4

Completed

Conditions: Nicotine Dependence
E-Cig Use

Interventions: Behavioral: Phone Counseling
Drug: Nicotine patch
Behavioral: Digital Coaching

Registration Number: NCT04974580

Lead Sponsor: Ohio State University

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 508

Inclusion Criteria

Current, regular user of nicotine e-cigarettes (20+ days in the last month)
Exclusive e-cigarette user (no other tobacco in the last 30 days; or no other tobacco in the last 90 days if smoked 100+ cigarettes or cigarillos in lifetime)
Interest in quitting in the next 30 days
Ownership of a smartphone device
Ability to speak and read English

Exclusion Criteria

Pregnant or breastfeeding
Individuals with schizophrenia or bipolar disorder who do not report that their condition is currently effectively managed
Individuals who have experienced a heart attack or stroke in the two weeks prior, or who have been diagnosed with rapid/irregular heartbeat or angina in the six months prior to taking the eligibility screener
Other household members in study

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
CoachingOnlyArm	Phone Counseling	Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
DigitalArm	Phone Counseling	Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
DigitalArm	Digital Coaching	Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
CoachingNRTArm	Nicotine patch	Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
DigitalNRTArm	Nicotine patch	This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
DigitalNRTArm	Phone Counseling	This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
CoachingNRTArm	Phone Counseling	Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
DigitalNRTArm	Digital Coaching	This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.

Primary Outcome Measures

Name	Time	Method
7-day Point Prevalence Vaping Abstinence	3 months after the first coaching call (occurred at baseline)	Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.

Secondary Outcome Measures

Name	Time	Method
Vaping Abstinence	Assessed 3 months after study enrollment	Self-reported 30-day point prevalence vaping abstinence
E-cigarette Dependence - PROMIS-E	Assessed 3 months after study enrollment	Self-reported e-cigarette dependence using the Patient Reported Outcomes Measurement Information System - E-cigarettes (PROMIS-E) questionnaire. Minimum t-score 0, maximum t-score 100. Larger scores indicate greater dependence.
E-cigarette Dependence - Penn State E-cigarette Dependence Index	Assessed 3 months after study enrollment	Self-reported e-cigarette dependence using the Penn State E-cigarette Dependence Index. The total score ranges from 0-20, with higher values indicating greater dependence.
Changes in E-cigarette Use Frequency	Assessed at baseline and 3 months after study enrollment	Self-reported e-cigarette use frequency in the last 30 days. Measured at baseline and 3 months after study enrollment and calculated as the change between these two time points (3 months - baseline).