Clinical trial NCT04315506: A Text-based Reduction Intervention for Smokeless Tobacco Cessation
Official title: A Text-based Reduction Intervention for Smokeless Tobacco Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smokeless Tobacco Cessation
Keywords: smokeless tobacco
quitting smokeless tobacco
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 532
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: Participants will be randomly assigned (like the flip of a coin) to one of the two groups after completing the baseline survey. Participants have a 50% of being in either the #EnufSnuff.TXT intervention group or the Enough Snuff Intervention group. Participants will then be given a baseline survey and the intervention will be explained to them.

Detailed description: Group 1: #EnufSnuff.TXT intervention For participants in the #EnufSnuff.TXT intervention, this program will occur for up to 10 weeks. The intent of this program is to reduce the number of times participants use smokeless tobacco to zero. Participants will also be provided with cessation support messages. During the first week, participants will be asked to use smokeless tobacco as per their regular habit. They will be required to text "s" every time they use smokeless tobacco . At the end of the week we will confirm how many times you dip a day on average. Based on this number participants will be texted a reduction schedule over the next several weeks to assist with cessation. During these weeks participants will be instructed not to use smokeless tobacco unless they receive a text message telling them to do so. Within 30 minutes after participants receive the text message, they will be required to respond to that message and text the study team "s" if they used smokeless tobacco. Participants will still be required to let the study team know if they used smokeless tobacco at a different time than the time we text participants. This will help the study team know if participants have followed the schedule or not. However, if the pattern continues then participants will receive a call from the study coordinator to reexamine their pattern of smokeless tobacco use and readjust your schedule.

Group 2: Enough Snuff Intervention group

Participants in the control group will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive two text messages a week from the study for ten weeks. These messages will reference the cessation manual.

End of Intervention and 3 and 6 Month Follow-up Assessments For both study groups, participants will be asked to take a follow-up survey at end of program and 6 months after the baseline survey. At three months all participants will be sent a brief assessment about smokeless tobacco use via text. If participants have reported to the study team that they have quit using smokeless tobacco, a small percentage of participants may be asked to provide a saliva sample to check for nicotine.

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: Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit)
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ)
timeFrame: Baseline, 3 months, and 6 months post-randomization
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: