Nicotine Dependence Clinical Trial
— (RISE)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: 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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | American Heart Association, Optum, Inc. |
United States,
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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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