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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 #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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| #EnufSnuff.TXT Intervention | Experimental | Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. |
|
| Enough Snuff Intervention | Active Comparator | Participants in this arm will be given the Enuff Snuff cessation manual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| #EnufSnuff.TXT Intervention | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devon Noonan, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39030750 | Derived | 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. |
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All participants recruited for the study using social media and other media advertisement outlets (i.e., Facebook, Instagram, Google Ads). An advertising profile for the study targeted the study population (e.g., smokeless tobacco users (chewer/dipper), over age 18, profiled for tobacco use) for rural and medically underserved counties in the U.S. This was a single- site study, which used electronic consents and survey measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | #EnufSnuff.TXT Intervention | Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use 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. |
| FG001 | Enough Snuff Intervention | Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | #EnufSnuff.TXT Intervention | Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Posted | Count of Participants | Participants | 6 months post-randomization |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | #EnufSnuff.TXT Intervention | Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devon Noonan | Duke University | 919-684-3786 | devon.noonan@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2022 | Jul 16, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2022 | Jul 16, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2022 | Oct 11, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| Enough Snuff Intervention | 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. |
|
| 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 |
| Physician Decision |
|
| BG001 | Enough Snuff Intervention | Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants in this arm will be given the Enuff Snuff cessation manual.
Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months post-randomization |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months post-randomization |
|
|
|
|
| 0 |
| 264 |
| 0 |
| 264 |
| 0 |
| 264 |
| EG001 | Enough Snuff Intervention | Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks. | 0 | 268 | 0 | 268 | 0 | 268 |
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| 6 Months |
|
| Superiority |
| 6 Months |
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| Superiority |