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

Primary Purpose

Nicotine Dependence, E-Cig Use

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nicotine patch
Phone Counseling
Digital Coaching
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CoachingOnlyArm

DigitalArm

CoachingNRTArm

DigitalNRTArm

Arm Description

Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Vaping abstinence
Self-reported 30-day point prevalence vaping abstinence
E-cigarette dependence - PROMIS-E
Self-reported e-cigarette dependence using the Patient Reported Outcomes Measurement Information System - E-cigarettes (PROMIS-E) questionnaire
E-cigarette dependence - Penn State E-cigarette Dependence Questionnaire
Self-reported e-cigarette dependence using the Penn State E-cigarette Dependence questionnaire
Changes in e-cigarette use frequency
Self-reported e-cigarette use frequency (changes in number of days vaped in the last 30 days)

Full Information

First Posted
July 2, 2021
Last Updated
October 3, 2022
Sponsor
Ohio State University
Collaborators
American Heart Association, Optum, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04974580
Brief Title
Research and Innovation to Stop E-cigarette/Vaping in Young Adults
Acronym
(RISE)
Official Title
Young Adult Vaping Cessation: A Randomized Trial Examining Phone Coaching, Text-based Digital Intervention, and Nicotine Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
American Heart Association, Optum, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: 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). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, E-Cig Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
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).
Masking
Outcomes Assessor
Masking Description
Evaluators are blinded to the study arm assignment of participants.
Allocation
Randomized
Enrollment
513 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CoachingOnlyArm
Arm Type
Experimental
Arm Description
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Arm Title
DigitalArm
Arm Type
Experimental
Arm Description
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.
Arm Title
CoachingNRTArm
Arm Type
Experimental
Arm Description
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.
Arm Title
DigitalNRTArm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Other Intervention Name(s)
Nicotine lozenge, Nicotine gum
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Phone Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital Coaching
Intervention Description
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).
Primary Outcome Measure Information:
Title
7-day point prevalence vaping abstinence
Description
Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.
Time Frame
3 months after Call 1
Secondary Outcome Measure Information:
Title
Vaping abstinence
Description
Self-reported 30-day point prevalence vaping abstinence
Time Frame
Assessed 3 months after study enrollment
Title
E-cigarette dependence - PROMIS-E
Description
Self-reported e-cigarette dependence using the Patient Reported Outcomes Measurement Information System - E-cigarettes (PROMIS-E) questionnaire
Time Frame
Assessed 3 months after study enrollment
Title
E-cigarette dependence - Penn State E-cigarette Dependence Questionnaire
Description
Self-reported e-cigarette dependence using the Penn State E-cigarette Dependence questionnaire
Time Frame
Assessed 3 months after study enrollment
Title
Changes in e-cigarette use frequency
Description
Self-reported e-cigarette use frequency (changes in number of days vaped in the last 30 days)
Time Frame
Assessed 3 months after study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Hustead
Phone
614-688-0345
Email
hustead.7@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liz Klein, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hustead, MS
Phone
614-688-0345
Email
hustead.7@osu.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Klein, PhD
Phone
6142925424
Email
klein.232@osu.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Klein, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30763302
Citation
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Results Reference
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31442788
Citation
Leavens ELS, Stevens EM, Brett EI, Leffingwell TR, Wagener TL. JUUL in school: JUUL electronic cigarette use patterns, reasons for use, and social normative perceptions among college student ever users. Addict Behav. 2019 Dec;99:106047. doi: 10.1016/j.addbeh.2019.106047. Epub 2019 Jul 9.
Results Reference
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PubMed Identifier
31197320
Citation
Graham AL, Jacobs MA, Amato MS. Engagement and 3-Month Outcomes From a Digital E-Cigarette Cessation Program in a Cohort of 27 000 Teens and Young Adults. Nicotine Tob Res. 2020 Apr 21;22(5):859-860. doi: 10.1093/ntr/ntz097. No abstract available.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
Morean ME, Krishnan-Sarin S, S O'Malley S. Assessing nicotine dependence in adolescent E-cigarette users: The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Nicotine Dependence Item Bank for electronic cigarettes. Drug Alcohol Depend. 2018 Jul 1;188:60-63. doi: 10.1016/j.drugalcdep.2018.03.029. Epub 2018 Apr 26. Erratum In: Drug Alcohol Depend. 2020 Jan 1;206:107602.
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Research and Innovation to Stop E-cigarette/Vaping in Young Adults

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