A Text-based Reduction Intervention for Smokeless Tobacco Cessation

NCT ID: NCT04315506

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2023-01-28

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.

Conditions

Smokeless Tobacco Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

#EnufSnuff.TXT Intervention

Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.

Group Type: EXPERIMENTAL

#EnufSnuff.TXT Intervention

Intervention Type: BEHAVIORAL

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.

Enough Snuff Intervention

Participants in this arm will be given the Enuff Snuff cessation manual.

Group Type: ACTIVE_COMPARATOR

Enough Snuff Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

#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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Devon Noonan, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

References

Noonan D, Silva SG, Fish LJ, Simmons LA, Nwankwo N, Scherr K, Da Costa M, Sang E, Sanders C, Swinkels C, Garcia Ortiz N, Severson HH, Pollak KI. Randomized Controlled Trial of a Text-Based Smokeless Tobacco Cessation Intervention for Rural and Medically Underserved Communities. Nicotine Tob Res. 2024 Dec 23;27(1):132-142. doi: 10.1093/ntr/ntae182.

Reference Type: DERIVED

PMID: 39030750 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00103410

Identifier Type: -

Identifier Source: org_study_id