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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04974580
Other study ID # GR120236
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)

Brunnemann KD, Hoffmann D. The pH of tobacco smoke. Food Cosmet Toxicol. 1974 Feb;12(1):115-24. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. Review. — View Citation

Tackett AP, Keller-Hamilton B, Smith CE, Hébert 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. — View Citation

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. Erratum in: J Am Heart Assoc. 2019 Apr 16;8(8):e002293. — View Citation

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
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