Clinical trial NCT06637358: A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study
Official title: A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smokeless Tobacco Cessation
Keywords: Smokeless Tobacco
Quitting Smokeless Tobacco
Quit Coach
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as measured by the number of recruited individuals who enrolled
timeFrame: Baseline
measure: Feasibility as measured by the number of participants who left the study (attrition)
timeFrame: Up to 6 months
measure: Acceptability as measured by the number of participants who found the intervention useful
timeFrame: Up to 6 months
measure: Acceptability as measured by the number of participants who reported that the intervention received changed their smokeless tobacco use
timeFrame: Up to 6 months
measure: Acceptability as measured by the number of participants who reported that the intervention made them think about quitting
timeFrame: Up to 6 months
measure: Acceptability as measured by the number of participants who reported that they would recommend the program to a friend
timeFrame: Up to 6 months
measure: Preliminary efficacy as measured by the number of participants who quit smokeless tobacco by the end of treatment
timeFrame: Up to approximately 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Devon Noonan, PhD
role: PRINCIPAL_INVESTIGATOR
References: