Nicotine Dependence, E-Cig Use
Conditions
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. 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.
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.
Interventions
DRUGNicotine 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.
BEHAVIORALPhone 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.
BEHAVIORALDigital 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).
Sponsors
American Heart Association
Optum, Inc.
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluators are blinded to the study arm assignment of participants.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Vaping Abstinence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaping Abstinence | Assessed 3 months after study enrollment | Self-reported 30-day point prevalence vaping abstinence |
| E-cigarette Dependence - PROMIS-E | Assessed 3 months after study enrollment | 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. |
| E-cigarette Dependence - Penn State E-cigarette Dependence Index | Assessed 3 months after study enrollment | 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. |
| Changes in E-cigarette Use Frequency | Assessed at baseline and 3 months after study enrollment | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 134 |
| 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). | 126 |
| 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. | 126 |
| 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). | 122 |
| Total | 508 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 33 | 39 | 30 | 29 |
Baseline characteristics
| Characteristic | CoachingOnlyArm | DigitalArm | CoachingNRTArm | DigitalNRTArm | Total |
|---|---|---|---|---|---|
| Age, Customized Age Category 18-21 years old | 76 Participants | 80 Participants | 71 Participants | 63 Participants | 290 Participants |
| Age, Customized Age Category 22-24 years old | 58 Participants | 46 Participants | 55 Participants | 59 Participants | 218 Participants |
| Daily E-cigarette use, baseline Daily E-cigarette use at baseline | 99 Participants | 97 Participants | 96 Participants | 103 Participants | 395 Participants |
| Daily E-cigarette use, baseline Less than daily use at baseline | 35 Participants | 29 Participants | 29 Participants | 19 Participants | 112 Participants |
| E-cigarette use 30+ times per day Use <30 times per day | 94 Participants | 73 Participants | 74 Participants | 68 Participants | 309 Participants |
| E-cigarette use 30+ times per day Use 30+ times per day | 38 Participants | 48 Participants | 46 Participants | 51 Participants | 183 Participants |
| Race/Ethnicity, Customized Race/Ethnicity All others | 20 Participants | 21 Participants | 14 Participants | 11 Participants | 66 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black / African | 11 Participants | 12 Participants | 13 Participants | 7 Participants | 43 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 84 Participants | 86 Participants | 92 Participants | 88 Participants | 350 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic / Latinx | 19 Participants | 7 Participants | 7 Participants | 15 Participants | 48 Participants |
| Sex/Gender, Customized Gender Female | 97 Participants | 92 Participants | 85 Participants | 88 Participants | 362 Participants |
| Sex/Gender, Customized Gender Male | 34 Participants | 30 Participants | 34 Participants | 28 Participants | 126 Participants |
| Sex/Gender, Customized Gender Other identity | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 9 Participants |
| Sex/Gender, Customized Gender Transgender female | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Gender Transgender male | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 134 | 0 / 126 | 0 / 126 | 0 / 122 |
| other Total, other adverse events | 14 / 102 | 10 / 87 | 33 / 96 | 33 / 94 |
| serious Total, serious adverse events | 0 / 134 | 0 / 126 | 0 / 126 | 0 / 122 |
Outcome results
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.
Time frame: 3 months after the first coaching call (occurred at baseline)
Population: All participants who were fully enrolled at baseline are included. Those missing outcome data are imputed as not abstinent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CoachingOnlyArm | 7-day Point Prevalence Vaping Abstinence | 55 Participants |
| DigitalArm | 7-day Point Prevalence Vaping Abstinence | 54 Participants |
| CoachingNRTArm | 7-day Point Prevalence Vaping Abstinence | 61 Participants |
| DigitalNRTArm | 7-day Point Prevalence Vaping Abstinence | 59 Participants |
Comparison: Comparison of NRT vs. no-NRT in model adjusted for receipt of digital componentp-value: 0.1495% CI: [0.91, 1.84]Regression, Logistic
Comparison: Comparison of Digital vs. no Digital in model adjusted for receipt of NRT componentp-value: 0.8495% CI: [0.73, 1.47]Regression, Logistic
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).
Time frame: Assessed at baseline and 3 months after study enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CoachingOnlyArm | Changes in E-cigarette Use Frequency | -7.9 Vaping days past month | Standard Deviation 9 |
| DigitalArm | Changes in E-cigarette Use Frequency | -6.9 Vaping days past month | Standard Deviation 9.3 |
| CoachingNRTArm | Changes in E-cigarette Use Frequency | -9.3 Vaping days past month | Standard Deviation 9.9 |
| DigitalNRTArm | Changes in E-cigarette Use Frequency | -5.5 Vaping days past month | Standard Deviation 10 |
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.
Time frame: Assessed 3 months after study enrollment
Population: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoachingOnlyArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Not dependent (0-3) | 1 Participants |
| CoachingOnlyArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Low dependence (4-8) | 10 Participants |
| CoachingOnlyArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Medium dependence (9-12) | 8 Participants |
| CoachingOnlyArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | High dependence (13+ | 7 Participants |
| DigitalArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Low dependence (4-8) | 1 Participants |
| DigitalArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Medium dependence (9-12) | 3 Participants |
| DigitalArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | High dependence (13+ | 11 Participants |
| DigitalArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Not dependent (0-3) | 1 Participants |
| CoachingNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Medium dependence (9-12) | 9 Participants |
| CoachingNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Low dependence (4-8) | 5 Participants |
| CoachingNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | High dependence (13+ | 4 Participants |
| CoachingNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Not dependent (0-3) | 4 Participants |
| DigitalNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | High dependence (13+ | 9 Participants |
| DigitalNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Low dependence (4-8) | 3 Participants |
| DigitalNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Not dependent (0-3) | 0 Participants |
| DigitalNRTArm | E-cigarette Dependence - Penn State E-cigarette Dependence Index | Medium dependence (9-12) | 3 Participants |
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.
Time frame: Assessed 3 months after study enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CoachingOnlyArm | E-cigarette Dependence - PROMIS-E | -5.5 change in t-score | Standard Deviation 10.3 |
| DigitalArm | E-cigarette Dependence - PROMIS-E | -2.6 change in t-score | Standard Deviation 7.8 |
| CoachingNRTArm | E-cigarette Dependence - PROMIS-E | -6.5 change in t-score | Standard Deviation 10.5 |
| DigitalNRTArm | E-cigarette Dependence - PROMIS-E | -7.3 change in t-score | Standard Deviation 11 |
Secondary
Vaping Abstinence
Self-reported 30-day point prevalence vaping abstinence
Time frame: Assessed 3 months after study enrollment
Population: All participants who were fully enrolled at baseline are included. Those missing outcome data are imputed as not abstinent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CoachingOnlyArm | Vaping Abstinence | 46 Participants |
| DigitalArm | Vaping Abstinence | 45 Participants |
| CoachingNRTArm | Vaping Abstinence | 52 Participants |
| DigitalNRTArm | Vaping Abstinence | 53 Participants |