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

NCT06637358 | Completed

• 1 other identifier: Pro00103410 _1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smokeless Tobacco Cessation

Keywords

Smokeless Tobacco; Quitting Smokeless Tobacco; Quit Coach

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Extended Scheduled Gradual Reduction (SGR)

ACTIVE COMPARATOR

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

Behavioral: Extended Scheduled Gradual Reduction (SGR)

Quit Coach and Extended Scheduled Gradual Reduction (SGR)

EXPERIMENTAL

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); Behavioral: Quit Coach

Interventions

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.

Extended Scheduled Gradual Reduction (SGR); Quit Coach and Extended Scheduled Gradual Reduction (SGR)

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.

Quit Coach and Extended Scheduled Gradual Reduction (SGR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Devon Noonan, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 5, 2024
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)