Tobacco Use Cessation
Conditions
Keywords
Digital intervention
Brief summary
The Cessation Clinical Trial will investigate the effectiveness of a digital quit tobacco program in promoting abstinence from tobacco product use compared to usual care.
Interventions
BEHAVIORALTruth Initiative Digital Cessation Program
Truth Initiative's digital cessation program is a multimodal evidence-based, digital tobacco cessation program. Accessible on any web-enabled device, it was developed with the Mayo Clinic around tobacco dependence treatment guidelines, Social Cognitive Theory, and the Mayo Clinic model for engaging tobacco users in cessation treatment. It includes a personalized quit plan with AI-driven content recommendations, interactive exercises, educational videos, and emails; a dynamically tailored, bidirectional text message program; the longest-running online community dedicated to tobacco cessation; synchronous live chat coaching (sponsored version only); and pharmacotherapy decision support and delivery (sponsored version only).
BEHAVIORALUsual Care
Smokefree.gov is a web-based tobacco cessation platform run by the National Cancer Institute of the National Institutes of Health since 2003 and represents the current standard of care for digital tobacco cessation in the U.S. As of 2020, the SmokeFree.gov Initiative (SFGI) consisted of a multimodal suite of interventions - 6 mobile-optimized websites, 9 text messaging programs, 2 mobile apps, and social media platforms.
Sponsors
Truth Initiative
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Data collection staff will be blinded to study condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current tobacco use (past 30-day use of one or more of the following: cigarettes, cigars, little cigars, cigarillos, e-cigarettes, or oral nicotine products) * US residence * Active text message plan (phase 2 only)
Exclusion criteria
* Age 25 or above (phase 2 only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day point prevalent abstinence | 7-months post randomization | 30-day point prevalent abstinence from user's primary product to quit indicated at enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence from all tobacco products | 7 months post randomization | Abstinence from any combustible tobacco product and any nicotine-containing product. Past 30-day abstinence will be measured for the following tobacco/nicotine products one by one and a combined total abstinence measure will be calculated based on these responses. Measurement item: In the past 30 days, which of the following products have you used at all (i.e., even a puff/hit)? Response options are Yes/No for each item. * Cigarettes * E-cigarettes * Chew * Dip * Nicotine pouches * Cigars/little cigars/cigarillos |
Countries
United States
Outcome results
None listed