A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study (NCT06637358) | Clinical Trial Compass
CompletedNot Applicable
A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study
United States69 participantsStarted 2024-11-05
Plain-language summary
All participants will receive the EnufSnuff.TXT scheduled gradual reduction (SGR) intervention for 6 weeks and, for those who do not reach the point of quit, includes getting randomized (like the flip of a coin) into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated text quit coach to send and receive live support.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age and older
. Have used smokeless tobacco for the last year, currently dip 3 or more times a day
. Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower
. Interested in participating in a cessation program; and
. Have access to a cell phone with unlimited texting ability.
Exclusion criteria
. Non-English speaking;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility as measured by the number of recruited individuals who enrolled
Timeframe: Baseline
2
Feasibility as measured by the number of participants who left the study (attrition)
Timeframe: Up to 6 months
3
Acceptability as measured by the number of participants who found the intervention useful
Timeframe: Up to 6 months
4
Acceptability as measured by the number of participants who reported that the intervention received changed their smokeless tobacco use
Timeframe: Up to 6 months
5
Acceptability as measured by the number of participants who reported that the intervention made them think about quitting
Timeframe: Up to 6 months
6
Acceptability as measured by the number of participants who reported that they would recommend the program to a friend
Timeframe: Up to 6 months
7
Preliminary efficacy as measured by the number of participants who quit smokeless tobacco by the end of treatment
. Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user) and are not willing to abstain during the intervention period
. Currently participating in a smokeless tobacco cessation study.