A Text-based Reduction Intervention for Smokeless Tobacco Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smokeless Tobacco Cessation
• Intervention / Treatment: Behavioral: #EnufSnuff.TXT Intervention; Behavioral: Enough Snuff Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 532
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: #EnufSnuff.TXT Intervention; Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.	Behavioral: #EnufSnuff.TXT Intervention; The SGR program will reduce smokeless tobacco 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.
Active Comparator: Enough Snuff Intervention; Participants in this arm will be given the Enuff Snuff cessation manual.	Behavioral: Enough Snuff Intervention; 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 ten weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit)	Measured by self-report. Number of participants who replied "no" the following: "In the past 7 days, have you used chew/dip?- Yes or No".	6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS)	The MNWS is a seven-item scale that measures withdrawal symptoms (i.e., irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia) during the past 24 hours. Each item was measured using a Likert scale (with 0 = not present to 4 = severe). A nicotine withdrawal total score was derived by summing the scores for the 7-items, with a possible range from 0 to 28, and higher scores indicating greater withdrawal.	Baseline, 3 months, and 6 months post-randomization
Change in Craving as Measured by 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 (0= not at all to 7=Extremely). The tool has five subscales: chewing satisfaction, psychological reward, enjoyment of sensations in cheek/gum, craving reduction, and aversion. To assess change in craving, the one item craving reduction subscale was used for this analysis. The question was "Did chewing/dipping immediately relieve your craving for smokeless tobacco?". The possible range was 0= not at all to 7=Extremely. At each timepoint, a higher score on this item indicated greater withdrawal symptom in terms of craving relief. Thus, a decrease in the mean craving reduction score across time indicates an improvement in the withdrawal symptoms specific to craving.	Baseline, 3 months, and 6 months post-randomization

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Devon Noonan, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): January 28, 2023
• Study Completion (Actual): January 28, 2023

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: smokeless tobacco; quitting smokeless tobacco
• Other Study ID Numbers: Pro00103410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No