- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05111041
Smokeless Tobacco Cessation Intervention for Firefighters
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Courtney Hausfeld
- Phone Number: 919-660-1689
- Email: courtney.hausfeld@duke.edu
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: #EnufSnuff.TXT- First Responder
Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention
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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.
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Active Comparator: Enough Snuff Intervention
Participants in this group will receive tobacco cessation materials
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of participants recruited as measured by enrollment log
Time Frame: Up to 3 months
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Up to 3 months
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Percent of participants enrolled as measured by enrollment log
Time Frame: Up to 3 months
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Up to 3 months
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Percent of participants who are still engaged with the program after 30 days
Time Frame: Up to 30 days
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Up to 30 days
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Percent of firefighters who stated intervention was useful as measured by questionnaire
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Percent of firefighters who stated intervention changed smokeless tobacco use as measured by questionnaire
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Percent of firefighters who stated intervention made them think about quitting as measured by questionnaire
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Percent of firefighters who stated they would recommend program to a friend as measured by questionnaire
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Percent of participants who quit smokeless tobacco measured by self report
Time Frame: Up to 16 weeks
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Up to 16 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Devon Noonan, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00109404
- 5R01CA242593-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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