Nicotine DependencePhase 4(RISE)NCT04974580
Research and Innovation to Stop E-cigarette/Vaping in Young Adults
A Phase 4 study testing Nicotine patch, Phone Counseling and Digital Coaching in people with Nicotine Dependence and E-Cig Use, run by Ohio State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, E-Cig Use
- What is being tested?
- Nicotine patch, Phone Counseling and Digital Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 30 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Young Adult Vaping Cessation: A Randomized Trial Examining Phone Coaching, Text-based Digital Intervention, and Nicotine Replacement Therapy
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:
Read more
- 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.
Read the 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.
- Conditions
- Nicotine Dependence, E-Cig Use
- Being tested
- Nicotine patch, Phone Counseling, Digital Coaching
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Nicotine lozenge, Nicotine gum
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 CounselingBehavioural
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 CoachingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Nicotine patch; Behavioral: Phone Counseling; Behavioral: Digital Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the first coaching call (occurred at baseline)
Secondary outcomes (4)
Vaping Abstinence
Self-reported 30-day point prevalence vaping abstinence
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Assessed at baseline and 3 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start28 Jul 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Optum, Inc.
- Responsible party
- Principal investigator, Elizabeth G Klein, Ohio State University
- Investigators
- Elizabeth G Klein, PhD, Principal investigator, Ohio State University College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974580
- Sponsor's protocol ID
- GR120236
- Acronym
- (RISE)
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2021
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30763302Leavens 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.
PubMed 31442788Graham 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.
PubMed 31197320Brunnemann 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.
PubMed 4459223Buchanan 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.
PubMed 31696222Tanwar 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.
PubMed 30561255Tackett 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.
PubMed 33048131Rogers 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.
PubMed 18383133Morean 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.
PubMed 29753155Foulds 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.
PubMed 25332459Vickerman 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.
PubMed 39665734
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adult Vaping Cessation: A Randomized Trial Examining Phone Coaching, Text-based Digital Intervention, and Nicotine Replacement Therapy
- ClinicalTrials.gov ID
- NCT04974580
- Acronym / sponsor ID
- (RISE) / GR120236
- Conditions
- Nicotine Dependence, E-Cig Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, Optum, Inc.
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| CoachingOnlyArm | Experimental | Behavioral: Phone CounselingPhone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive. |
| DigitalArm | Experimental | Behavioral: Phone Counseling, Behavioral: Digital CoachingPhone 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 | Drug: Nicotine patch, Behavioral: Phone CounselingPhone 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 | Drug: Nicotine patch, Behavioral: Phone Counseling, Behavioral: Digital CoachingThis 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchAlso: Nicotine lozenge, Nicotine gumNRT 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. | Drug | CoachingNRTArm, DigitalNRTArm |
| Phone CounselingParticipants 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. | Behavioural | CoachingNRTArm, CoachingOnlyArm, DigitalArm, DigitalNRTArm |
| Digital CoachingIntervention 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). | Behavioural | DigitalArm, DigitalNRTArm |
Primary outcome
7-day Point Prevalence Vaping Abstinence
Time frame: 3 months after the first coaching call (occurred at baseline)
Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.
4 secondary outcomes
Vaping Abstinence
Time frame: Assessed 3 months after study enrollment
E-cigarette Dependence - PROMIS-E
Time frame: Assessed 3 months after study enrollment
E-cigarette Dependence - Penn State E-cigarette Dependence Index
Time frame: Assessed 3 months after study enrollment
Changes in E-cigarette Use Frequency
Time frame: Assessed at baseline and 3 months after study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30763302Gentzke 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.
- Background: PubMed 31442788Leavens 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.
- Background: PubMed 31197320Graham 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.
- Background: PubMed 4459223Brunnemann 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.
- Background: PubMed 31696222Buchanan 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.
- Background: PubMed 30561255Tanwar 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.
- Background: PubMed 33048131Tackett 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.
- Background: PubMed 18383133Rogers 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.
- Background: PubMed 29753155Morean 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.
- Background: PubMed 25332459Foulds 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.
- Derived from this study: PubMed 39665734Vickerman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth G Klein, PhD principal investigator
Ohio State University College of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch, Phone Counseling and Digital Coaching in people with Nicotine Dependence and E-Cig Use, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Point Prevalence Vaping Abstinence (time frame: 3 months after the first coaching call (occurred at baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974580, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.