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.

Study Overview

• Status: Completed
• Conditions: Smokeless Tobacco Cessation
• Intervention / Treatment: Behavioral: Extended Scheduled Gradual Reduction (SGR); Behavioral: Quit Coach

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: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by the number of recruited individuals who enrolled		Baseline
Feasibility as measured by the number of participants who left the study (attrition)		Up to 6 months
Acceptability as measured by the number of participants who found the intervention useful	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	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	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	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		Up to approximately 16 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Devon Noonan, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): November 4, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Smokeless Tobacco; Quitting Smokeless Tobacco; Quit Coach
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Tobacco Use; Tobacco Use Cessation
• Other Study ID 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