Smokeless Tobacco Cessation Intervention for Firefighters

Smokeless Tobacco Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111041
• Other study ID #: Pro00109404
• Secondary ID: 5R01CA242593-03
• Status: Completed
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smokeless Tobacco Cessation

Intervention

Behavioral:
• #EnufSnuff.TXT- First Responder
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
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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants recruited as measured by enrollment log		Up to 3 months
Primary	Percent of participants enrolled as measured by enrollment log		Up to 3 months
Primary	Percent of participants who are still engaged with the program after 30 days		Up to 30 days
Primary	Percent of firefighters who stated intervention was useful as measured by questionnaire		Up to 12 weeks
Primary	Percent of firefighters who stated intervention changed smokeless tobacco use as measured by questionnaire		Up to 12 weeks
Primary	Percent of firefighters who stated intervention made them think about quitting as measured by questionnaire		Up to 12 weeks
Primary	Percent of firefighters who stated they would recommend program to a friend as measured by questionnaire		Up to 12 weeks
Primary	Percent of participants who quit smokeless tobacco measured by self report		Up to 16 weeks