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

NCT04974580 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GR120236
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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. 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. 2.Does 8 weeks of nicotine replacement therapy (NRT) improve initial cessation outcomes relative to no NRT.
3. 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.

Conditions

Nicotine Dependence; E-Cig Use

Outcome Measures

Primary Outcomes (1)

• 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 the first coaching call (occurred at baseline)

Secondary Outcomes (4)

• Vaping Abstinence

  Assessed 3 months after study enrollment

• E-cigarette Dependence - PROMIS-E

  Assessed 3 months after study enrollment

• E-cigarette Dependence - Penn State E-cigarette Dependence Index

  Assessed 3 months after study enrollment

• Changes in E-cigarette Use Frequency

  Assessed at baseline and 3 months after study enrollment

Study Arms (4)

CoachingOnlyArm

EXPERIMENTAL

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

Behavioral: Phone Counseling

DigitalArm

EXPERIMENTAL

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.

Behavioral: Phone Counseling; Behavioral: Digital Coaching

CoachingNRTArm

EXPERIMENTAL

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.

Drug: Nicotine patch; Behavioral: Phone Counseling

DigitalNRTArm

EXPERIMENTAL

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.

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

Interventions

Nicotine patch DRUG

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.

Also known as: Nicotine lozenge, Nicotine gum

CoachingNRTArm; DigitalNRTArm

Phone Counseling BEHAVIORAL

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.

CoachingNRTArm; CoachingOnlyArm; DigitalArm; DigitalNRTArm

Digital Coaching BEHAVIORAL

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).

DigitalArm; DigitalNRTArm

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• American Heart Association: collaborator
• Optum, Inc.: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (11)

• Gentzke AS, Creamer M, Cullen KA, Ambrose BK, Willis G, Jamal A, King BA. Vital Signs: Tobacco Product Use Among Middle and High School Students - United States, 2011-2018. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):157-164. doi: 10.15585/mmwr.mm6806e1.

  PMID: 30763302 BACKGROUND

• 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.

  PMID: 31442788 BACKGROUND

• 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.

  PMID: 31197320 BACKGROUND

• Brunnemann KD, Hoffmann D. The pH of tobacco smoke. Food Cosmet Toxicol. 1974 Feb;12(1):115-24. doi: 10.1016/0015-6264(74)90327-7. No abstract available.

  PMID: 4459223 BACKGROUND

• Buchanan ND, Grimmer JA, Tanwar V, Schwieterman N, Mohler PJ, Wold LE. Cardiovascular risk of electronic cigarettes: a review of preclinical and clinical studies. Cardiovasc Res. 2020 Jan 1;116(1):40-50. doi: 10.1093/cvr/cvz256.

  PMID: 31696222 BACKGROUND

• Tanwar V, Adelstein JM, Grimmer JA, Youtz DJ, Katapadi A, Sugar BP, Falvo MJ, Baer LA, Stanford KI, Wold LE. Preconception Exposure to Fine Particulate Matter Leads to Cardiac Dysfunction in Adult Male Offspring. J Am Heart Assoc. 2018 Dec 18;7(24):e010797. doi: 10.1161/JAHA.118.010797.

  PMID: 30561255 BACKGROUND

• Tackett AP, Keller-Hamilton B, Smith CE, Hebert ET, Metcalf JP, Queimado L, Stevens EM, Wallace SW, McQuaid EL, Wagener TL. Evaluation of Respiratory Symptoms Among Youth e-Cigarette Users. JAMA Netw Open. 2020 Oct 1;3(10):e2020671. doi: 10.1001/jamanetworkopen.2020.20671.

  PMID: 33048131 BACKGROUND

• Rogers JM. Tobacco and pregnancy: overview of exposures and effects. Birth Defects Res C Embryo Today. 2008 Mar;84(1):1-15. doi: 10.1002/bdrc.20119.

  PMID: 18383133 BACKGROUND

• 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.

  PMID: 29753155 BACKGROUND

• Foulds J, Veldheer S, Yingst J, Hrabovsky S, Wilson SJ, Nichols TT, Eissenberg T. Development of a questionnaire for assessing dependence on electronic cigarettes among a large sample of ex-smoking E-cigarette users. Nicotine Tob Res. 2015 Feb;17(2):186-92. doi: 10.1093/ntr/ntu204. Epub 2014 Oct 19.

  PMID: 25332459 BACKGROUND

• Vickerman KA, Carpenter KM, Mullis K, Shoben AB, Nemeth J, Mayers E, Klein EG. Quitline-Based Young Adult Vaping Cessation: A Randomized Clinical Trial Examining NRT and mHealth. Am J Prev Med. 2025 Feb;68(2):366-376. doi: 10.1016/j.amepre.2024.10.019. Epub 2024 Dec 11.

  PMID: 39665734 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Elizabeth G. Klein
• Organization: Ohio State University College of Public Health

klein.232@osu.edu

614-292-5424

Study Officials

• Elizabeth G Klein, PhD

  Ohio State University College of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluators are blinded to the study arm assignment of participants.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 23, 2021
• Study Start: July 28, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)