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

Nicotine Dependence Clinical Trial

— (RISE)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04974580
• Other study ID #: GR120236
• Status: Recruiting
• Phase: Phase 4
• Start date: July 5, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2022
• Source: Ohio State University
• Contact: Elizabeth Hustead
• Phone: 614-688-0345
• Email: hustead.7[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 513
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	American Heart Association, Optum, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence vaping abstinence	Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.	3 months after Call 1
Secondary	Vaping abstinence	Self-reported 30-day point prevalence vaping abstinence	Assessed 3 months after study enrollment
Secondary	E-cigarette dependence - PROMIS-E	Self-reported e-cigarette dependence using the Patient Reported Outcomes Measurement Information System - E-cigarettes (PROMIS-E) questionnaire	Assessed 3 months after study enrollment
Secondary	E-cigarette dependence - Penn State E-cigarette Dependence Questionnaire	Self-reported e-cigarette dependence using the Penn State E-cigarette Dependence questionnaire	Assessed 3 months after study enrollment
Secondary	Changes in e-cigarette use frequency	Self-reported e-cigarette use frequency (changes in number of days vaped in the last 30 days)	Assessed 3 months after study enrollment