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Research and Innovation to Stop E-cigarette/Vaping in Young Adults
Phase 4 trial testing Nicotine patch in Nicotine Dependence in 508 participants. Completed in 30 December 2022.
| Lead sponsor | Ohio State University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 508 |
| Start date | 28 July 2021 |
| Primary completion | 30 December 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across United States |
Ohio State University
Adults 18 to 24, any sex, with Nicotine Dependence or E-Cig Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.
| Group | Value | 95% CI |
|---|---|---|
| CoachingOnlyArm | 55 | |
| DigitalArm | 54 | |
| CoachingNRTArm | 61 | |
| DigitalNRTArm | 59 |
Self-reported 30-day point prevalence vaping abstinence
| Group | Value | 95% CI |
|---|---|---|
| CoachingOnlyArm | 46 | |
| DigitalArm | 45 | |
| CoachingNRTArm | 52 | |
| DigitalNRTArm | 53 |
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.
| Group | Value | 95% CI |
|---|---|---|
| CoachingOnlyArm | -5.5 | ± 10.3 |
| DigitalArm | -2.6 | ± 7.8 |
| CoachingNRTArm | -6.5 | ± 10.5 |
| DigitalNRTArm | -7.3 | ± 11.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| CoachingOnlyArm | 1 | |
| DigitalArm | 1 | |
| CoachingNRTArm | 4 | |
| DigitalNRTArm | 0 | |
| CoachingOnlyArm | 10 | |
| DigitalArm | 1 | |
| CoachingNRTArm | 5 | |
| DigitalNRTArm | 3 | |
| CoachingOnlyArm | 8 | |
| DigitalArm | 3 | |
| CoachingNRTArm | 9 | |
| DigitalNRTArm | 3 | |
| CoachingOnlyArm | 7 | |
| DigitalArm | 11 | |
| CoachingNRTArm | 4 | |
| DigitalNRTArm | 9 |
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).
| Group | Value | 95% CI |
|---|---|---|
| CoachingOnlyArm | -7.9 | ± 9.0 |
| DigitalArm | -6.9 | ± 9.3 |
| CoachingNRTArm | -9.3 | ± 9.9 |
| DigitalNRTArm | -5.5 | ± 10.0 |
Time frame: During study participation (3 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CoachingOnlyArm | DigitalArm | CoachingNRTArm | DigitalNRTArm |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | — | — | — | — |
| Nausea / upset stomach | Gastrointestinal disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Sore or dry mouth | Gastrointestinal disorders | — | — | — | — |
| Sleeplessness / trouble sleeping | Nervous system disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Bad or vivid dreams / nightmares | Psychiatric disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT04974580 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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