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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Optum, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Vaping Abstinence | Self-reported 30-day point prevalence vaping abstinence | Assessed 3 months after study enrollment |
| E-cigarette Dependence - PROMIS-E | Self-reported e-cigarette dependence using the Patient Reported Outcomes Measurement Information System - E-cigarettes (PROMIS-E) questionnaire. Minimum t-score 0, maximum t-score 100. Larger scores indicate greater dependence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth G Klein, PhD | Ohio State University College of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30763302 | Background | 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. | |
| 31442788 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CoachingOnlyArm | Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive. 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. |
| FG001 | DigitalArm | 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 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). |
| FG002 | CoachingNRTArm | 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. 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. 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. |
| FG003 | DigitalNRTArm | 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. 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. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CoachingOnlyArm | Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who were fully enrolled at baseline are included. Those missing outcome data are imputed as not abstinent. | Posted | Count of Participants | Participants | 3 months after the first coaching call (occurred at baseline) |
|
During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CoachingOnlyArm | Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth G. Klein | Ohio State University College of Public Health | 614-292-5424 | klein.232@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2021 | Jul 13, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2021 | Jul 13, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2021 | Jul 13, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 |
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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).
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Evaluators are blinded to the study arm assignment of participants.
|
|
| 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. |
|
| 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). |
|
| Assessed 3 months after study enrollment |
| E-cigarette Dependence - Penn State E-cigarette Dependence Index | Self-reported e-cigarette dependence using the Penn State E-cigarette Dependence Index. The total score ranges from 0-20, with higher values indicating greater dependence. | Assessed 3 months after study enrollment |
| Changes in E-cigarette Use Frequency | Self-reported e-cigarette use frequency in the last 30 days. Measured at baseline and 3 months after study enrollment and calculated as the change between these two time points (3 months - baseline). | Assessed at baseline and 3 months after study enrollment |
| 31197320 | 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. |
| 4459223 | 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. |
| 31696222 | 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. |
| 30561255 | 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. |
| 33048131 | 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. |
| 18383133 | 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. |
| 29753155 | 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. |
| 25332459 | 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. |
| 39665734 | Derived | 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. |
| BG001 | DigitalArm | 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 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). |
| BG002 | CoachingNRTArm | 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. 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. 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. |
| BG003 | DigitalNRTArm | 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. 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. 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). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey). | Count of Participants | Participants |
|
| Daily E-cigarette use, baseline | Missing data on one participant (due to not answering a question on the baseline survey). | Count of Participants | Participants |
|
| E-cigarette use 30+ times per day | Missing data on 16 participants (due to not answering a question on the baseline survey). | Count of Participants | Participants |
|
| OG001 | DigitalArm | 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 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). |
| OG002 | CoachingNRTArm | 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. 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. 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. |
| OG003 | DigitalNRTArm | 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. 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. 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). |
|
|
|
| Secondary | Vaping Abstinence | Self-reported 30-day point prevalence vaping abstinence | All participants who were fully enrolled at baseline are included. Those missing outcome data are imputed as not abstinent. | Posted | Count of Participants | Participants | 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. Minimum t-score 0, maximum t-score 100. Larger scores indicate greater dependence. | Participants who were not 7 day point prevalence abstinent at the 3-month follow up survey and had complete PROMIS-E data at both baseline and the 3-month follow up survey. | Posted | Mean | Standard Deviation | change in t-score | Assessed 3 months after study enrollment |
|
|
|
| Secondary | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Self-reported e-cigarette dependence using the Penn State E-cigarette Dependence Index. The total score ranges from 0-20, with higher values indicating greater dependence. | Participants who were not 7-day point prevalence abstinent at the 3-month survey and completed all questions as required by the PSU dependence questionnaire | Posted | Count of Participants | Participants | Assessed 3 months after study enrollment |
|
|
|
| Secondary | Changes in E-cigarette Use Frequency | Self-reported e-cigarette use frequency in the last 30 days. Measured at baseline and 3 months after study enrollment and calculated as the change between these two time points (3 months - baseline). | Participants who were not 7-day point prevalence abstinent at the 3-month survey and were not missing data on number of days vaped in the past 30 on either the 3-month or baseline survey. | Posted | Mean | Standard Deviation | Vaping days past month | Assessed at baseline and 3 months after study enrollment |
|
|
|
| 0 |
| 134 |
| 0 |
| 134 |
| 14 |
| 102 |
| EG001 | DigitalArm | 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 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). | 0 | 126 | 0 | 126 | 10 | 87 |
| EG002 | CoachingNRTArm | 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. 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. 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. | 0 | 126 | 0 | 126 | 33 | 96 |
| EG003 | DigitalNRTArm | 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. 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. 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). | 0 | 122 | 0 | 122 | 33 | 94 |
| Sore or dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Sleeplessness / trouble sleeping | Nervous system disorders | Systematic Assessment |
|
| Bad or vivid dreams / nightmares | Psychiatric disorders | Systematic Assessment |
|
| Nausea / upset stomach | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D001519 |
| Behavior |
| Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| 22-24 years old |
|
| Male |
|
| Transgender female |
|
| Transgender male |
|
| Other identity |
|
| Black / African |
|
| Hispanic / Latinx |
|
| All others |
|
| Less than daily use at baseline |
|
| Use <30 times per day |
|
| Low dependence (4-8) |
|
| Medium dependence (9-12) |
|
| High dependence (13+ |
|