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Active, Not Recruiting

NCT Number: NCT06806098

Cessation Clinical Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Truth Initiative

Washington D.C., District of Columbia, 20001, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Truth Initiative Digital Cessation Program

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).

Usual Care

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.

Primary outcomes

  1. 30-day point prevalent abstinence

    Time frame: 7-months post randomization

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

Secondary outcomes

  1. Abstinence from all tobacco products

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Truth Initiative

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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