Clinical trial NCT04974580: Research and Innovation to Stop E-cigarette/Vaping in Young Adults
Official title: Young Adult Vaping Cessation: A Randomized Trial Examining Phone Coaching, Text-based Digital Intervention, and Nicotine Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Dependence
E-Cig Use
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Optum, Inc.
First posted: 2021-07-23
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 2x2 factorial design will be used where all participants receive quitline-delivered phone counseling, and components to be tested are a digital intervention (with text-based cessation and online cessation support) and nicotine replacement therapy (NRT).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-day Point Prevalence Vaping Abstinence
timeFrame: 3 months after the first coaching call (occurred at baseline)
Secondary outcomes:
measure: Vaping Abstinence
timeFrame: Assessed 3 months after study enrollment
measure: E-cigarette Dependence - PROMIS-E
timeFrame: Assessed 3 months after study enrollment
measure: E-cigarette Dependence - Penn State E-cigarette Dependence Index
timeFrame: Assessed 3 months after study enrollment
measure: Changes in E-cigarette Use Frequency
timeFrame: Assessed at baseline and 3 months after study enrollment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University College of Public Health
name: Elizabeth G Klein, PhD
role: PRINCIPAL_INVESTIGATOR
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