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

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.

Conditions

• Nicotine Dependence
• E-Cig Use

Interventions

DRUG

Nicotine patch

NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.

BEHAVIORAL

Phone Counseling

Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.

BEHAVIORAL

Digital Coaching

Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• Optum, Inc.

  collaborator INDUSTRY

• Ohio State University

  lead OTHER

Principal Investigators

• Elizabeth G Klein, PhD · Ohio State University College of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-28

Primary Completion

2022-12-30

Completion

2022-12-30

FDA Drug

Yes

Countries

• United States

Study Locations