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Clinical Trial Summary

Participants will be randomly assigned (like the flip of a coin) to one of the two groups after completing the baseline survey. Participants have a 50% of being in either the Scheduled Gradual Reduction (SGR) group or the control group. Participants will then be given a baseline survey and the intervention will be explained to them.


Clinical Trial Description

Group 1: SGR Program For participants in the SGR program, this program will occur for up to 12 weeks. The intent of this program is to reduce the number of times participants use smokeless tobacco to zero by reducing their tobacco use by 1/4th each week. Participants will also be provided with cessation support messages. During the first week, participants will be asked to use smokeless tobacco as per their regular habit. They will be required to text "s" every time they use smokeless tobacco . At the end of the week we will confirm how many times you dip a day on average. Based on this number participants will be texted a reduction schedule over the next several weeks to assist with cessation. During these weeks participants will be instructed not to use smokeless tobacco unless they receive a text message telling them to do so. Within 30 minutes after participants receive the text message, they will be required to respond to that message and text the study team "s" if they used smokeless tobacco. Participants will still be required to let the study team know if they used smokeless tobacco at a different time than the time we text participants. This will help the study team know if participants have followed the schedule or not. However, if the pattern continues then participants will receive a call from the study coordinator to reexamine their pattern of smokeless tobacco use and readjust your schedule. Group 2: Control Group Participants in the control group will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive two text messages a week from the study for five weeks. These messages will reference the cessation manual. End of Intervention and 3 and 6 Month Follow-up Assessments For both study groups, participants will be asked to take a follow-up survey at end of program and 6 months after the baseline survey. At three months all participants will be sent a brief assessment about smokeless tobacco use via text. If participants have reported to the study team that they have quit using smokeless tobacco, a small percentage of participants may be asked to provide a saliva sample to check for nicotine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04315506
Study type Interventional
Source Duke University
Contact
Status Completed
Phase N/A
Start date October 16, 2020
Completion date January 28, 2023

See also
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