Smokeless Tobacco Cessation
Conditions
Keywords
smokeless tobacco, quitting smokeless tobacco
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.
Interventions
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.
BEHAVIORALEnough 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit) | 6 months post-randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) | Baseline, 3 months, and 6 months post-randomization | 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. |
| Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) | Baseline, 3 months, and 6 months post-randomization | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| #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. | 264 |
| 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. | 268 |
| Total | 532 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 74 | 82 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 8 |
Baseline characteristics
| Characteristic | #EnufSnuff.TXT Intervention | Total | Enough Snuff Intervention |
|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 11.9 | 44.9 years STANDARD_DEVIATION 11.9 | 45.1 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 257 Participants | 512 Participants | 255 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) White | 257 Participants | 512 Participants | 255 Participants |
| Region of Enrollment United States | 264 Participants | 532 Participants | 268 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 262 Participants | 528 Participants | 266 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 264 | 0 / 268 |
| other Total, other adverse events | 0 / 264 | 0 / 268 |
| serious Total, serious adverse events | 0 / 264 | 0 / 268 |
Outcome results
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.
Time frame: 6 months post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| #EnufSnuff.TXT Intervention | Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit) | 61 Participants |
| Enough Snuff Intervention | Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit) | 56 Participants |
p-value: 0.538495% CI: [0.75, 1.72]Regression, Logistic
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.
Time frame: Baseline, 3 months, and 6 months post-randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| #EnufSnuff.TXT Intervention | Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) | Baseline | 5.1 score on a scale | Standard Deviation 1.6 |
| #EnufSnuff.TXT Intervention | Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) | 3 Months | 5.0 score on a scale | Standard Deviation 1.5 |
| #EnufSnuff.TXT Intervention | Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) | 6 Months | 4.7 score on a scale | Standard Deviation 1.6 |
| Enough Snuff Intervention | Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) | Baseline | 5.1 score on a scale | Standard Deviation 1.5 |
| Enough Snuff Intervention | Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) | 3 Months | 4.8 score on a scale | Standard Deviation 1.6 |
| Enough Snuff Intervention | Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) | 6 Months | 4.6 score on a scale | Standard Deviation 1.7 |
Comparison: For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.p-value: 0.23295% CI: [-0.0609, 0.2501]Mixed Models Analysis
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.
Time frame: Baseline, 3 months, and 6 months post-randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| #EnufSnuff.TXT Intervention | Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) | Baseline | 7.3 score on a scale | Standard Deviation 6.3 |
| #EnufSnuff.TXT Intervention | Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) | 3 Months | 6.3 score on a scale | Standard Deviation 5.2 |
| #EnufSnuff.TXT Intervention | Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) | 6 Months | 5.8 score on a scale | Standard Deviation 5.8 |
| Enough Snuff Intervention | Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) | Baseline | 7.1 score on a scale | Standard Deviation 5.7 |
| Enough Snuff Intervention | Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) | 3 Months | 5.9 score on a scale | Standard Deviation 5.4 |
| Enough Snuff Intervention | Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) | 6 Months | 5.4 score on a scale | Standard Deviation 5.4 |
Comparison: For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.p-value: 0.662495% CI: [-0.5808, 0.3693]Mixed Models Analysis