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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05111041
Other study ID # Pro00109404
Secondary ID 5R01CA242593-03
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT04315506 - A Text-based Reduction Intervention for Smokeless Tobacco Cessation N/A
Completed NCT01341938 - Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation N/A
Completed NCT02613689 - Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention N/A
Completed NCT03418506 - Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco N/A