Smokeless Tobacco CessationNCT05111041
Smokeless Tobacco Cessation Intervention for Firefighters
A study testing #EnufSnuff.TXT- First Responder and Enough Snuff Intervention in people with Smokeless Tobacco Cessation, run by Duke University at 1 site in United States.
Trial summary
The investigators are asking professional firefighters across North Carolina to take part in focus groups to discuss the specific needs of firefighters in smokeless tobacco cessation. About 40 firefighters will take part in the focus groups. 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?
- #EnufSnuff.TXT- First Responder and Enough Snuff Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Professional firefighters or first responders
- 18 years or older
- Have used smokeless tobacco for the past year and current (past 30 days) smokeless tobacco daily use
- Access to a smartphone
Who cannot join
- Not a professional firefighter or first responder
- Under 18 years of age
- Have not used smokeless tobacco for the past year and are not current (past 30 days) smokeless tobacco daily use
- No access to a smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a M-Health Smokeless Tobacco Cessation Intervention for Firefighters
The investigators are asking professional firefighters across North Carolina to take part in focus groups to discuss the specific needs of firefighters in smokeless tobacco cessation. About 40 firefighters will take part in the focus groups.
The purpose of the focus groups is to learn how firefighting and shift work impact smokeless tobacco use and risk perceptions related to chew or dip. Using their feedback, the study team will then develop a cessation program specifically geared towards firefighters and first responders.
The cessation program will be a mobile text / chat intervention specifically tailored to needs of firefighters and first responders who wish to stop using smokeless tobacco. About 50 firefighters and first responders will take part in this program, while being randomized into either the intervention group or the control group.
- Conditions
- Smokeless Tobacco Cessation
- Being tested
- #EnufSnuff.TXT- First Responder, Enough Snuff Intervention
- Keywords
- Firefighters, Smokeless Tobacco, Quitting Smokeless Tobacco, First Responders
- 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.
#EnufSnuff.TXT- First ResponderBehavioural
Participants in this intervention will be given the choice of following the Gradual Reduction to Quit program or to choose their own quit date within 2-4 weeks. The Gradual Reduction to Quit program will reduce smokeless tobacco use via text message support and weekly prompts guiding the participants to gradually decrease their use of smokeless tobacco until they are down to zero. A four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges will also be provided to all participants. The intent of this program is to reduce the number of times participants use smokeless tobacco.
Enough Snuff InterventionBehavioural
Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
| Study group | Role | What they receive |
|---|---|---|
| #EnufSnuff.TXT- First Responder | Experimental | Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention Receives: Behavioral: #EnufSnuff.TXT- First Responder |
| Enough Snuff Intervention | Active comparator | Participants in this group will receive tobacco cessation materials Receives: Behavioral: Enough Snuff Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of First Responders Recruited Who Completed a Screening Assessment
Measured: Within 3 months of the initiation of study recruitment
First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm
Measured: Within 3 months of the initiation of study recruitment
Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire
Study engagement defined as completing the End of Intervention Program assessment.
Measured: 30 days following the end of the 10-week intervention
Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire
Usefulness was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Measured: 30 days following the end of the 10-week intervention
Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire
Helpfulness was measured on a scale of 1-5 where 1=not at all, 2=somewhat, 3=Undecided, 4=very, 5=extremely. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) and 1=yes (very, extremely).
Measured: 30 days following the end of the 10-week intervention
Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire
Considered quitting was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Measured: 30 days following the end of the 10-week intervention
Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire
Recommend to friend was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were then dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Measured: 30 days following the end of the 10-week intervention
Number of Participants Who Quit Smokeless Tobacco Measured by Self Report
Quit was determined by the self-report response (yes or no) to the question, "In the past 7 days, have you used any dip?"
Measured: 30 days following the end of the 10-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start25 Jan 2022
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Devon Noonan, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111041
- Sponsor's protocol ID
- Pro00109404
- Other IDs
- 5R01CA242593-03
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2021
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noonan D, Fish LJ, Silva SG, Da Costa M, Simmons LA, Garcia Ortiz N, Swinkels C, Jung D, Severson HH, Pollak KI. #EnufSnuff.TXT-FirstResponder: a pilot randomized controlled trial of a text message intervention for smokeless tobacco cessation among First Responders. Front Public Health. 2026 Jan 19;13:1699800. doi: 10.3389/fpubh.2025.1699800. eCollection 2025.
PubMed 41635441
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a M-Health Smokeless Tobacco Cessation Intervention for Firefighters
- ClinicalTrials.gov ID
- NCT05111041
- Acronym / sponsor ID
- Pro00109404
- Conditions
- Smokeless Tobacco Cessation
- Keywords
- Firefighters, Smokeless Tobacco, Quitting Smokeless Tobacco, First Responders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are asking professional firefighters across North Carolina to take part in focus groups to discuss the specific needs of firefighters in smokeless tobacco cessation. About 40 firefighters will take part in the focus groups.
The purpose of the focus groups is to learn how firefighting and shift work impact smokeless tobacco use and risk perceptions related to chew or dip. Using their feedback, the study team will then develop a cessation program specifically geared towards firefighters and first responders.
The cessation program will be a mobile text / chat intervention specifically tailored to needs of firefighters and first responders who wish to stop using smokeless tobacco. About 50 firefighters and first responders will take part in this program, while being randomized into either the intervention group or the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #EnufSnuff.TXT- First Responder | Experimental | Behavioral: #EnufSnuff.TXT- First ResponderParticipants in this group will receive a mobile gradual smokeless tobacco reduction intervention |
| Enough Snuff Intervention | Active comparator | Behavioral: Enough Snuff InterventionParticipants in this group will receive tobacco cessation materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Professional firefighters or first responders
- 18 years or older
- Have used smokeless tobacco for the past year and current (past 30 days) smokeless tobacco daily use
- Access to a smartphone
Key exclusion criteria (4 listed)
- Not a professional firefighter or first responder
- Under 18 years of age
- Have not used smokeless tobacco for the past year and are not current (past 30 days) smokeless tobacco daily use
- No access to a smartphone
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 |
|---|---|---|
| #EnufSnuff.TXT- First ResponderParticipants in this intervention will be given the choice of following the Gradual Reduction to Quit program or to choose their own quit date within 2-4 weeks. The Gradual Reduction to Quit program will reduce smokeless tobacco use via text message support and weekly prompts guiding the participants to gradually decrease their use of smokeless tobacco until they are down to zero. A four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges will also be provided to all participants. The intent of this program is to reduce the number of times participants use smokeless tobacco. | Behavioural | #EnufSnuff.TXT- First Responder |
| Enough Snuff InterventionParticipants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges. | Behavioural | Enough Snuff Intervention |
Primary outcome
Number of First Responders Recruited Who Completed a Screening Assessment
Time frame: Within 3 months of the initiation of study recruitment
First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm
Time frame: Within 3 months of the initiation of study recruitment
Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire
Time frame: 30 days following the end of the 10-week intervention
Study engagement defined as completing the End of Intervention Program assessment.
Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire
Time frame: 30 days following the end of the 10-week intervention
Usefulness was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire
Time frame: 30 days following the end of the 10-week intervention
Helpfulness was measured on a scale of 1-5 where 1=not at all, 2=somewhat, 3=Undecided, 4=very, 5=extremely. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) and 1=yes (very, extremely).
Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire
Time frame: 30 days following the end of the 10-week intervention
Considered quitting was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire
Time frame: 30 days following the end of the 10-week intervention
Recommend to friend was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were then dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Number of Participants Who Quit Smokeless Tobacco Measured by Self Report
Time frame: 30 days following the end of the 10-week intervention
Quit was determined by the self-report response (yes or no) to the question, "In the past 7 days, have you used any dip?"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41635441Noonan D, Fish LJ, Silva SG, Da Costa M, Simmons LA, Garcia Ortiz N, Swinkels C, Jung D, Severson HH, Pollak KI. #EnufSnuff.TXT-FirstResponder: a pilot randomized controlled trial of a text message intervention for smokeless tobacco cessation among First Responders. Front Public Health. 2026 Jan 19;13:1699800. doi: 10.3389/fpubh.2025.1699800. eCollection 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 #EnufSnuff.TXT- First Responder and Enough Snuff Intervention 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 4 inclusion and 4 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 13 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of First Responders Recruited Who Completed a Screening Assessment (time frame: Within 3 months of the initiation of study recruitment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111041, which also lists 1 linked publication.
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 13 Dec 2024.