Smokeless Tobacco CessationNCT06637358
A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study
A study testing Extended Scheduled Gradual Reduction (SGR) and Quit Coach in people with Smokeless Tobacco Cessation, run by Duke University at 1 site in United States.
Trial summary
All participants will receive the EnufSnuff.TXT scheduled gradual reduction (SGR) intervention for 6 weeks and, for those who do not reach the point of quit, includes getting randomized (like the flip of a coin) into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smokeless Tobacco Cessation
- What is being tested?
- Extended Scheduled Gradual Reduction (SGR) and Quit Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 4 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
- 18 years of age and older
- Have used smokeless tobacco for the last year, currently dip 3 or more times a day
- Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower
- Interested in participating in a cessation program; and
- Have access to a cell phone with unlimited texting ability.
Who cannot join
- Non-English speaking;
- Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user) and are not willing to abstain during the intervention period
- Currently participating in a smokeless tobacco cessation study.
Trial locations and contacts
1 site in 1 country.
About this study
All participants will receive the EnufSnuff.TXT scheduled gradual reduction (SGR) intervention for 6 weeks and, for those who do not reach the point of quit, includes getting randomized (like the flip of a coin) into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated text quit coach to send and receive live support.
Read the detailed description
All participants will receive the EnufSnuff.TXT intervention (a text-based personalized reduction plan and daily text-based cessation support messages) for 6 weeks and, for those who report that they have not achieved complete cessation, includes getting randomized into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated quit coach to send and receive live text support. The investigators will conduct phone-based or smart phone-based assessments with participants at baseline, end of program, and 7-month follow-up after intervention completion. The investigators will also conduct a brief midpoint check (after the first 6 weeks of intervention) with participants to ask if they have quit using smokeless tobacco. Research staff will email participants redcap surveys at baseline, end of program, and 7-months. Participants will be able to opt for a recorded telephone interview at the 7-month check-in. Each opted-in participant will be interviewed only once.
- Conditions
- Smokeless Tobacco Cessation
- Being tested
- Extended Scheduled Gradual Reduction (SGR), Quit Coach
- Keywords
- Smokeless Tobacco, Quitting Smokeless Tobacco, Quit Coach
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Scheduled Gradual Reduction (SGR)Behavioural
The extended SGR program will allow participants additional time to reduce smokeless tobacco use until they reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.
Quit CoachBehavioural
Weekly check-ins and support will be given to this group via the quit coach interactions. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.
| Study group | Role | What they receive |
|---|---|---|
| Extended Scheduled Gradual Reduction (SGR) | Active comparator | Extended scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. Receives: Behavioral: Extended Scheduled Gradual Reduction (SGR) |
| Quit Coach and Extended Scheduled Gradual Reduction (SGR) | Experimental | Extended scheduled gradual reduction given with the extra support of a live text-based coach. Participants are asked to gradually reduce smokeless tobacco usage and engage in weekly check-ins with their assigned quit coach. Receives: Behavioral: Extended Scheduled Gradual Reduction (SGR); Behavioral: Quit Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by the number of recruited individuals who enrolled
Measured: Baseline
Feasibility as measured by the number of participants who left the study (attrition)
Measured: Up to 6 months
Acceptability as measured by the number of participants who found the intervention useful
As measured via telephone interview.
Measured: Up to 6 months
Acceptability as measured by the number of participants who reported that the intervention received changed their smokeless tobacco use
As measured via telephone interview.
Measured: Up to 6 months
Acceptability as measured by the number of participants who reported that the intervention made them think about quitting
As measured via telephone interview.
Measured: Up to 6 months
Acceptability as measured by the number of participants who reported that they would recommend the program to a friend
As measured via telephone interview.
Measured: Up to 6 months
Preliminary efficacy as measured by the number of participants who quit smokeless tobacco by the end of treatment
Measured: Up to approximately 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Nov 2024
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smokeless Tobacco CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devon Noonan, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637358
- Sponsor's protocol ID
- Pro00103410 _1
- Status last verified
- Dec 2025
- First submitted
- 9 Oct 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study
- ClinicalTrials.gov ID
- NCT06637358
- Acronym / sponsor ID
- Pro00103410 _1
- Conditions
- Smokeless Tobacco Cessation
- Keywords
- Smokeless Tobacco, Quitting Smokeless Tobacco, Quit Coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 15 Oct 2024 (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.
All participants will receive the EnufSnuff.TXT scheduled gradual reduction (SGR) intervention for 6 weeks and, for those who do not reach the point of quit, includes getting randomized (like the flip of a coin) into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated text quit coach to send and receive live support.
Detailed description
All participants will receive the EnufSnuff.TXT intervention (a text-based personalized reduction plan and daily text-based cessation support messages) for 6 weeks and, for those who report that they have not achieved complete cessation, includes getting randomized into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated quit coach to send and receive live text support. The investigators will conduct phone-based or smart phone-based assessments with participants at baseline, end of program, and 7-month follow-up after intervention completion. The investigators will also conduct a brief midpoint check (after the first 6 weeks of intervention) with participants to ask if they have quit using smokeless tobacco. Research staff will email participants redcap surveys at baseline, end of program, and 7-months. Participants will be able to opt for a recorded telephone interview at the 7-month check-in. Each opted-in participant will be interviewed only once.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Scheduled Gradual Reduction (SGR) | Active comparator | Behavioral: Extended Scheduled Gradual Reduction (SGR)Extended scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. |
| Quit Coach and Extended Scheduled Gradual Reduction (SGR) | Experimental | Behavioral: Extended Scheduled Gradual Reduction (SGR), Behavioral: Quit CoachExtended scheduled gradual reduction given with the extra support of a live text-based coach. Participants are asked to gradually reduce smokeless tobacco usage and engage in weekly check-ins with their assigned quit coach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Have used smokeless tobacco for the last year, currently dip 3 or more times a day
- Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower
- Interested in participating in a cessation program; and
- Have access to a cell phone with unlimited texting ability.
Key exclusion criteria (3 listed)
- Non-English speaking;
- Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user) and are not willing to abstain during the intervention period
- Currently participating in a smokeless tobacco cessation study.
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 |
|---|---|---|
| Extended Scheduled Gradual Reduction (SGR)The extended SGR program will allow participants additional time to reduce smokeless tobacco use until they reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages. | Behavioural | Extended Scheduled Gradual Reduction (SGR), Quit Coach and Extended Scheduled Gradual Reduction (SGR) |
| Quit CoachWeekly check-ins and support will be given to this group via the quit coach interactions. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages. | Behavioural | Quit Coach and Extended Scheduled Gradual Reduction (SGR) |
Primary outcome
Feasibility as measured by the number of recruited individuals who enrolled
Time frame: Baseline
Feasibility as measured by the number of participants who left the study (attrition)
Time frame: Up to 6 months
Acceptability as measured by the number of participants who found the intervention useful
Time frame: Up to 6 months
As measured via telephone interview.
Acceptability as measured by the number of participants who reported that the intervention received changed their smokeless tobacco use
Time frame: Up to 6 months
As measured via telephone interview.
Acceptability as measured by the number of participants who reported that the intervention made them think about quitting
Time frame: Up to 6 months
As measured via telephone interview.
Acceptability as measured by the number of participants who reported that they would recommend the program to a friend
Time frame: Up to 6 months
As measured via telephone interview.
Preliminary efficacy as measured by the number of participants who quit smokeless tobacco by the end of treatment
Time frame: Up to approximately 16 weeks
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Devon Noonan, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Scheduled Gradual Reduction (SGR) and Quit Coach in people with Smokeless Tobacco Cessation, run by Duke University 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 5 inclusion and 3 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 16 Dec 2025. 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?
Feasibility as measured by the number of recruited individuals who enrolled (time frame: Baseline). The study lists 7 primary outcomes in all. 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 16 Dec 2025.