A Text-based Reduction Intervention for Smokeless Tobacco Cessation

Smokeless Tobacco Cessation Clinical Trial

Official title:

A Text-based Reduction Intervention for Smokeless Tobacco Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315506
• Other study ID #: Pro00103410
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: January 28, 2023

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smokeless Tobacco Cessation

Intervention

Behavioral:
• SGR
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.
• Control
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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of people who quit smokeless tobacco measured by self-report		Six-months post intervention
Secondary	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
Secondary	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