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

Duke University

Status: Enrolling

Conditions: Smokeless Tobacco Cessation

Treatments: Behavioral: Extended Scheduled Gradual Reduction (SGR); Behavioral: Quit Coach

Study type: Interventional

Funder types: Other

Identifiers

NCT06637358

Pro00103410 _1

Details and patient eligibility

About

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.

Full 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 6-month follow-up after intervention completion. The investigators will also conduct a brief midpoint check (in between end of program and 6-month follow-up assessment) with participants to ask if they have quit using smokeless tobacco. Research staff will email participants redcap surveys at baseline, end of program, midpoint check in, and 6-months. Participants will be able to opt for a recorded telephone interview at EOP (12-week) and 6-month. Each opted-in participant will be interviewed only once (i.e., if a participant is interviewed at 12- week, they will not be interviewed at 6-month).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Extended Scheduled Gradual Reduction (SGR)

Active Comparator group

Description:

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

Treatment:

Behavioral: Extended Scheduled Gradual Reduction (SGR)

Quit Coach and Extended Scheduled Gradual Reduction (SGR)

Experimental group

Description:

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.

Treatment:

Behavioral: Quit Coach

Behavioral: Extended Scheduled Gradual Reduction (SGR)