Tobacco Use CessationNCT06806098
Cessation Clinical Trial
A study testing Truth Initiative Digital Cessation Program in people with Tobacco Use Cessation, run by Truth Initiative at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Truth Initiative Digital Cessation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,555 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Age 25 or above (phase 2 only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Truth Initiative
Washington D.C., District of Columbia, 20001
About this study
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
- Being tested
- Truth Initiative Digital Cessation Program, Usual Care
- Keywords
- Digital intervention
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truth Initiative Digital Cessation ProgramBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sponsored cessation intervention | Experimental | Intervention arm receiving sponsored version only available for enterprise client users. Receives: Behavioral: Truth Initiative Digital Cessation Program |
| Usual Care | Active comparator | Usual care control arm receiving referral to a free digital cessation program Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day point prevalent abstinence
30-day point prevalent abstinence from user's primary product to quit indicated at enrollment
Measured: 7-months post randomization
Secondary outcomes (1)
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
Measured: 7 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start5 Dec 2024
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Truth Initiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda L. Graham, PhD, Truth Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806098
- Sponsor's protocol ID
- CessationClinicalTrial
- Status last verified
- Aug 2026
- First submitted
- 13 Nov 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified dataset will be available for replication purposes with a Data Sharing Agreement with Truth Initiative.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cessation Clinical Trial
- ClinicalTrials.gov ID
- NCT06806098
- Acronym / sponsor ID
- CessationClinicalTrial
- Conditions
- Tobacco Use Cessation
- Keywords
- Digital intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,555 participants (actual)
- Lead sponsor
- Truth InitiativeUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sponsored cessation intervention | Experimental | Behavioral: Truth Initiative Digital Cessation ProgramIntervention arm receiving sponsored version only available for enterprise client users. |
| Usual Care | Active comparator | Behavioral: Usual CareUsual care control arm receiving referral to a free digital cessation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Age 25 or above (phase 2 only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Truth Initiative Digital Cessation ProgramTruth 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). | Behavioural | Sponsored cessation intervention |
| Usual CareSmokefree.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. | Behavioural | Usual Care |
Primary outcome
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
1 secondary outcome
Abstinence from all tobacco products
Time frame: 7 months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. Deidentified dataset will be available for replication purposes with a Data Sharing Agreement with Truth Initiative.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Truth Initiative Digital Cessation Program in people with Tobacco Use Cessation, run by Truth Initiative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day point prevalent abstinence (time frame: 7-months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.