A Text-based Reduction Intervention for Smokeless Tobacco Cessation

Study Overview
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Brief Summary
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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 Scheduled Gradual Reduction (SGR) group or the control group. Participants will then be given a baseline survey and the intervention will be explained to them.

Detailed Description
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Group 1: SGR Program For participants in the SGR program, this program will occur for up to 12 weeks. The intent of this program is to reduce the number of times participants use smokeless tobacco to zero by reducing their tobacco use by 1/4th each week. 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: Control 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 five 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.

Official Title
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A Text-based Reduction Intervention for Smokeless Tobacco Cessation

Conditions
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Smokeless Tobacco Cessation

Intervention / Treatment
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* Behavioral: SGR
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGR<br>Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. | Behavioral: SGR<br>* The SGR program will reduce smokeless tobacco use by 1/4 until you 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.<br>|
| Active Comparator: Control group<br>Participants in this arm will be given the Enuff Snuff cessation manual. | Behavioral: Control<br>* Participants will be sent the Enough Snuff cessation manual. One weeks after it is sent, participants will then receive text messages from the study team twice a week for five weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of people who quit smokeless tobacco measured by self-report |  | Six-months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal | Minnesota Nicotine Withdrawal Scale. This seven-item scale measures withdrawal symptoms (i.e., irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia) and measured on an ordinal scale (0= not present) to 4 (severe). A total score ranging from 0 to 28 will be derived to measure severity of withdrawal symptoms, with higher total scores representing greater withdrawal. | Six months post intervention | 
| Craving | Smokeless Tobacco Evaluation Questionnaire (STEQ). The STEQ is a 12-item scale assessing the degree to which participants experience the reinforcing effects of smokeless tobacco on a 7-point Likert scale. The scale has five domains: chewing satisfaction, psychological reward, enjoyment of sensations in cheek/gum, craving reduction, and aversion. Higher scores indicate greater intensity of each tobacco use effect | Six months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smokeless tobacco, quitting smokeless tobacco