Cessation Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Data collection staff will be blinded to study condition.

Study Groups

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Usual Care

Usual care control arm receiving referral to a free digital cessation program

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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.

Free cessation intervention

Intervention arm receiving free version of a cessation intervention.

Group Type EXPERIMENTAL

Truth Initiative Digital Cessation Program

Intervention Type BEHAVIORAL

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).

Assessment-only

Periodic assessment check-ins only, no active intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Truth 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).

Intervention Type BEHAVIORAL

Usual 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)