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Completed

NCT Number: NCT05111041

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.

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Key information

Conditions

Smokeless Tobacco Cessation Behavior Health Behavior Tobacco Use Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

#EnufSnuff.TXT- First Responder

Behavioral

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 Intervention

Behavioral

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.

Primary outcomes

  1. Number of First Responders Recruited Who Completed a Screening Assessment

    Time frame: Within 3 months of the initiation of study recruitment

  2. 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

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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?"

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Development of a M-Health Smokeless Tobacco Cessation Intervention for Firefighters

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2021
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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