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

69 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment EnufSnuff.TXT for smokeless tobacco cessation?

Research shows that web and telephone-based programs are effective for helping people quit smokeless tobacco, and similar self-help methods like the Enough Snuff manual have shown success in helping people quit, with about 24.5% of users staying tobacco-free for six months. ^{1 2 3 4 5}

Is the Text-based Program for Smokeless Tobacco Cessation safe for humans?

The research articles provided do not contain specific safety data for the Text-based Program for Smokeless Tobacco Cessation or its other names. However, they do mention the use of self-help methods and telephone support for smokeless tobacco cessation, which are generally considered safe as they do not involve medication or invasive procedures. ^{1 3 4 5 6}

What makes the EnufSnuff.TXT treatment unique for smokeless tobacco cessation?

The EnufSnuff.TXT treatment is unique because it is a text-based program, which means it uses text messages to help people quit smokeless tobacco. This approach is different from traditional methods like medication or in-person counseling, offering a more accessible and convenient option for users. ^{7 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Devon Noonan, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Smokeless tobacco cessation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The inside scoop on the stuff called snuff: an interview study of 94 adult male smokeless tobacco users. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating two self-help interventions for smokeless tobacco cessation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Smokeless tobacco reduction: preliminary study of tobacco-free snuff versus no snuff. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A novel model mouth system for evaluation of In Vitro release of nicotine from moist snuff. [2022]

7. United States 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. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Interactive Pharmacometric Applications Using R and the Shiny Package. [2018]

9. England pubmed.ncbi.nlm.nih.gov

FAF-Drugs: free ADME/tox filtering of compound collections. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Rapid and accurate determination of the median lethal dose (LD50) and its error with a small computer. [2007]

11. Ireland pubmed.ncbi.nlm.nih.gov

PsN-Toolkit--a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. [2021]