Cessation Clinical Trial

Truth Initiative1,555 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,555

Conditions

Tobacco Use Cessation

Interventions

Truth Initiative Digital Cessation ProgramBEHAVIORAL

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).

Usual CareBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Truth Initiative

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

30-day point prevalent abstinence

30-day point prevalent abstinence from user's primary product to quit indicated at enrollment

Time frame: 7-months post randomization

Secondary Outcomes

Abstinence from all tobacco products

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

Time frame: 7 months post randomization

Data from ClinicalTrials.gov

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