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Completed

NCT Number: NCT06637358

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

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.

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Key information

Conditions

Smokeless Tobacco Cessation Behavior Health Behavior Tobacco Use Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

Extended Scheduled Gradual Reduction (SGR)

Behavioral

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.

Quit Coach

Behavioral

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.

Primary outcomes

  1. Feasibility as measured by the number of recruited individuals who enrolled

    Time frame: Baseline

  2. Feasibility as measured by the number of participants who left the study (attrition)

    Time frame: Up to 6 months

  3. Acceptability as measured by the number of participants who found the intervention useful

    Time frame: Up to 6 months

    As measured via telephone interview.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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