Text-based Program for Smokeless Tobacco Cessation

Overseen By Courtney Swinkels

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Non-English speaking, Dual user, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people quit using smokeless tobacco through a text-based program called EnufSnuff.TXT. Initially, participants will use a method to gradually reduce their tobacco use over six weeks. If quitting does not occur, participants will be randomly assigned to either continue with the program or receive additional support from a live text-based coach (Quit Coach) for 8-10 more weeks. Ideal candidates include those who have used smokeless tobacco for over a year, dip at least three times a day, live in rural areas, and have a cell phone with unlimited texting. As an unphased trial, this study offers a unique opportunity to access innovative support methods for quitting smokeless tobacco.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that text-based programs for quitting smokeless tobacco are generally safe and easy to use. The EnufSnuff.TXT program resembles other text-based methods for quitting tobacco, which maintain a good safety record.

Adding a quit coach who communicates through text messages is also safe. Whether coaching occurs by phone or text, it has proven effective in helping people quit tobacco without causing harm. These programs are low risk and have successfully assisted many in quitting tobacco.

Overall, evidence suggests that joining this program should not cause any harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Text-based Program for Smokeless Tobacco Cessation because it offers a fresh approach to quitting smokeless tobacco by combining structured reduction with personalized support. Unlike traditional methods like nicotine replacement therapy or prescription medications, this program leverages technology to guide users through a gradual reduction in usage. The standout feature is the "Quit Coach," a live text-based coaching system that provides customized advice and weekly check-ins, adding a personalized touch to the cessation process. This method not only makes quitting more interactive but also potentially more effective by addressing individual challenges in real-time.

What evidence suggests that this trial's treatments could be effective for smokeless tobacco cessation?

Research has shown that text messaging programs can help people quit smoking, leading to higher quitting rates compared to regular methods. One study found that a 12-week text messaging program significantly increased the number of people who reported quitting.

In this trial, participants in one arm will use the EnufSnuff.TXT program, which involves an extended scheduled gradual reduction (SGR) approach. Another arm will combine this approach with the support of a Quit Coach, providing live text-based coaching. Reports indicate that these coaches keep people engaged and offer personalized encouragement. Together, these tools could make quitting smokeless tobacco easier. ^{6 7 8 9 10}

Who Is on the Research Team?

Devon Noonan, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals who are trying to quit using smokeless tobacco. Participants should be willing to follow a text-based program over several weeks and interact with a quit coach if assigned. Specific eligibility criteria were not provided.

Inclusion Criteria

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

Have access to a cell phone with unlimited texting ability

Exclusion Criteria

Non-English speaking

Currently participating in a smokeless tobacco cessation study

I have used tobacco in the last 30 days and am not willing to stop during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the EnufSnuff.TXT scheduled gradual reduction intervention for 6 weeks

6 weeks

Daily text-based cessation support messages

Extended Treatment

Participants who do not quit are randomized to receive an additional 8-10 weeks of intervention, with or without a quit coach

8-10 weeks

Weekly check-ins with quit coach for some participants

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Phone-based assessments at baseline, end of program, midpoint, and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• EnufSnuff.TXT
• Quit Coach

Trial Overview

The study tests whether a text-based scheduled gradual reduction (SGR) method helps people stop using smokeless tobacco, comparing it with the same method plus live support from a quit coach.

How Is the Trial Designed?

Group I: Quit Coach and Extended Scheduled Gradual Reduction (SGR) Experimental Treatment 2 Interventions

Extended scheduled gradual reduction given with the extra support of a live text-based coach. Participants are asked to gradually reduce smokeless tobacco usage and engage in weekly check-ins with their assigned quit coach.

Group II: Extended Scheduled Gradual Reduction (SGR) Active Control 1 Intervention

Extended scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A study of 94 adult males found that 68% had attempted to quit smokeless tobacco, but most relapsed within 1 to 3 months, highlighting the challenges of cessation.

Despite high awareness of health risks associated with smokeless tobacco, only one-third of users received advice to quit from healthcare providers, indicating a need for improved cessation support in dental clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The inside scoop on the stuff called snuff: an interview study of 94 adult male smokeless tobacco users. Severson, HH., Eakin, EG., Lichtenstein, E., et al.[2019]

A study involving 1,683 smokeless tobacco users found that both a Web program and a Quitline were effective in helping users quit, significantly outperforming a self-help manual control.

However, combining the Web program and Quitline did not enhance quitting success compared to using either intervention alone, indicating that while both are beneficial, they do not work better together for smokeless tobacco cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation. Danaher, BG., Severson, HH., Zhu, SH., et al.[2022]

Shiny applications in R can significantly enhance the way pharmacometric model simulations are shared and communicated, allowing for real-time updates of simulation outputs based on user inputs.

The combination of Shiny and R enables the simulation of population variability, making it a powerful tool for visualizing complex pharmacometric models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Pharmacometric Applications Using R and the Shiny Package. Wojciechowski, J., Hopkins, AM., Upton, RN.[2018]

A digital computer program was created to accurately calculate the median lethal dose (LD50) of toxic compounds, showing high accuracy compared to traditional methods by Bliss.

The program not only improved calculation speed but also provided more precise results than simplified and graphic methods, demonstrating its effectiveness for analyzing four different toxic compounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid and accurate determination of the median lethal dose (LD50) and its error with a small computer. Rosiello, AP., Essignmann, JM., Wogan, GN.[2007]

A preliminary study with 106 smokeless tobacco users showed that using tobacco-free snuff for 8 weeks led to significant reductions in tobacco use and harmful biomarkers, such as urinary cotinine and total NNAL, a carcinogen.

Participants using tobacco-free snuff had a higher success rate in achieving at least a 50% reduction in cotinine levels and total NNAL, as well as more quit attempts and longer abstinence durations compared to those who did not use snuff, suggesting it may help reduce health risks associated with smokeless tobacco.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokeless tobacco reduction: preliminary study of tobacco-free snuff versus no snuff. Hatsukami, DK., Ebbert, JO., Edmonds, A., et al.[2020]

A novel model mouth system was developed to simulate human buccal conditions and evaluate the release of nicotine from pouch moist snuff, showing that 60-90% of nicotine is released after 30 minutes of use.

This system can serve as an alternative tool for assessing user exposure to harmful tobacco constituents, potentially aiding in the risk evaluation of smokeless tobacco products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel model mouth system for evaluation of In Vitro release of nicotine from moist snuff. Li, P., Zhang, J., Sun, SH., et al.[2022]

FAF-Drugs is an online tool that helps researchers filter compound collections for drug discovery by assessing key properties like absorption, distribution, metabolism, excretion, and toxicity (ADME/Tox).

By using simple filtering rules based on molecular characteristics, FAF-Drugs streamlines the process of preparing compounds for in silico screening, making it easier for scientists to identify promising drug candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FAF-Drugs: free ADME/tox filtering of compound collections. Miteva, MA., Violas, S., Montes, M., et al.[2023]

A study involving 198 smokeless tobacco users tested two self-help methods for quitting: the LifeSign device and the Enough Snuff manual/video, both supported by telephone assistance.

The manual/video condition resulted in a higher sustained abstinence rate of 24.5% at six months compared to 18.4% for the LifeSign device, indicating that traditional self-help methods may be more effective for ST cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating two self-help interventions for smokeless tobacco cessation. Severson, HH., Akers, L., Andrews, JA., et al.[2022]

A new program developed in BASIC language efficiently computes the median effective dose (LD50), error terms, and confidence intervals, enhancing the accuracy and speed of these calculations.

The program's algorithm is based on Finney's method, making it a flexible and effective alternative to traditional graphic methods for dose-response analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interactive computer program that accurately estimates the ED50, its standard error and other parameters related to the probit regression line. Hanes, B., Gocka, EF., Hanes, SD.[2007]

The PsN-Toolkit provides a user-friendly collection of statistical tools for pharmacometric data analysis, specifically designed to work with the NONMEM software, enhancing the efficiency of modeling and analysis.

It includes five key methods for data analysis—Bootstrap, Jackknife, Log-likelihood Profiling, Case-deletion Diagnostics, and Stepwise Covariate Model building—allowing for flexible and parallel execution on various computing environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PsN-Toolkit--a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Lindbom, L., Pihlgren, P., Jonsson, EN.[2021]

Smokeless tobacco use, particularly among young men in the U.S., is on the rise, highlighting the need for effective cessation resources.

The article presents a validated four-step clinical plan for quitting smokeless tobacco, supported by randomized clinical trials, which includes preparation, planning, quitting, and maintaining abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokeless tobacco cessation. Severson, HH., Hatsukami, D.[2019]

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