A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study

December 12, 2025 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants will receive the EnufSnuff.TXT intervention (a text-based personalized reduction plan and daily text-based cessation support messages) for 6 weeks and, for those who report that they have not achieved complete cessation, includes getting randomized 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 quit coach to send and receive live text support. The investigators will conduct phone-based or smart phone-based assessments with participants at baseline, end of program, and 7-month follow-up after intervention completion. The investigators will also conduct a brief midpoint check (after the first 6 weeks of intervention) with participants to ask if they have quit using smokeless tobacco. Research staff will email participants redcap surveys at baseline, end of program, and 7-months. Participants will be able to opt for a recorded telephone interview at the 7-month check-in. Each opted-in participant will be interviewed only once.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 18 years of age and older
  2. Have used smokeless tobacco for the last year, currently dip 3 or more times a day
  3. Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower
  4. Interested in participating in a cessation program; and
  5. Have access to a cell phone with unlimited texting ability.

Exclusion Criteria:

  1. Non-English speaking;
  2. 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
  3. Currently participating in a smokeless tobacco cessation study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Extended Scheduled Gradual Reduction (SGR)
Extended scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.
Behavioral: Extended Scheduled Gradual Reduction (SGR)
The extended SGR program will allow participants additional time to reduce smokeless tobacco use until they reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.
Experimental: Quit Coach and Extended Scheduled Gradual Reduction (SGR)
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.
Behavioral: Extended Scheduled Gradual Reduction (SGR)
The extended SGR program will allow participants additional time to reduce smokeless tobacco use until they reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.
Behavioral: Quit Coach
Weekly check-ins and support will be given to this group via the quit coach interactions. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility as measured by the number of recruited individuals who enrolled
Time Frame: Baseline
Baseline
Feasibility as measured by the number of participants who left the study (attrition)
Time Frame: Up to 6 months
Up to 6 months
Acceptability as measured by the number of participants who found the intervention useful
Time Frame: Up to 6 months
As measured via telephone interview.
Up to 6 months
Acceptability as measured by the number of participants who reported that the intervention received changed their smokeless tobacco use
Time Frame: Up to 6 months
As measured via telephone interview.
Up to 6 months
Acceptability as measured by the number of participants who reported that the intervention made them think about quitting
Time Frame: Up to 6 months
As measured via telephone interview.
Up to 6 months
Acceptability as measured by the number of participants who reported that they would recommend the program to a friend
Time Frame: Up to 6 months
As measured via telephone interview.
Up to 6 months
Preliminary efficacy as measured by the number of participants who quit smokeless tobacco by the end of treatment
Time Frame: Up to approximately 16 weeks
Up to approximately 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Devon Noonan, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00103410 _1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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