Cessation Clinical Trial

November 18, 2025 updated by: Amanda L. Graham, PhD, Truth Initiative
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20001
        • Truth Initiative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sponsored cessation intervention
Intervention arm receiving sponsored version only available for enterprise client users.
Behavioral: 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).
Active Comparator: Usual Care
Usual care control arm receiving referral to a free digital cessation program
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.
Experimental: Free cessation intervention
Intervention arm receiving free version of a cessation intervention.
Behavioral: 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).
No Intervention: Assessment-only
Periodic assessment check-ins only, no active intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7-months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Truth Initiative

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CessationClinicalTrial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified dataset will be available for replication purposes with a Data Sharing Agreement with Truth Initiative.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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