Cessation Clinical Trial

NCT06806098 | Active Not Recruiting

• 1 other identifier: CessationClinicalTrial
• Study Type: interventional
• Target: 2,220
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation

Keywords

Digital intervention

Outcome Measures

Primary Outcomes (1)

• 30-day point prevalent abstinence

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

  7-months post randomization

Secondary Outcomes (1)

• Abstinence from all tobacco products

  7 months post randomization

Study Arms (4)

Sponsored cessation intervention

EXPERIMENTAL

Intervention arm receiving sponsored version only available for enterprise client users.

Behavioral: Truth Initiative Digital Cessation Program

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Free cessation intervention

EXPERIMENTAL

Intervention arm receiving free version of a cessation intervention.

Behavioral: Truth Initiative Digital Cessation Program

Assessment-only

NO INTERVENTION

Periodic assessment check-ins only, no active intervention

Interventions

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).

Free cessation intervention; Sponsored cessation intervention

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Age 25 or above (phase 2 only)

Sponsors & Collaborators

• Truth Initiative: lead

Study Sites (1)

Truth Initiative

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

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Data collection staff will be blinded to study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Health Officer

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: February 3, 2025
• Study Start: December 5, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)