Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT04315506
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2020-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Text-based Reduction Intervention for Smokeless Tobacco Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'devon.noonan@duke.edu', 'phone': '919-684-3786', 'title': 'Devon Noonan', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': '#EnufSnuff.TXT Intervention', 'description': 'Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.\n\nSGR: 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.', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 264, 'otherNumAffected': 0, 'seriousNumAtRisk': 264, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enough Snuff Intervention', 'description': 'Participants in this arm will be given the Enuff Snuff cessation manual.\n\nControl: 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.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 0, 'seriousNumAtRisk': 268, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '#EnufSnuff.TXT Intervention', 'description': 'Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.\n\nSGR: 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.'}, {'id': 'OG001', 'title': 'Enough Snuff Intervention', 'description': 'Participants in this arm will be given the Enuff Snuff cessation manual.\n\nControl: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.72', 'pValueComment': 'The analysis was a two-intervention arm comparison. Adjustments for multiple tests and outcomes were not required.', 'estimateComment': 'Odds of quitting in Enuf Snuff group (SGR) compared to Enough Snuff (control)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-randomization', 'description': '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".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '#EnufSnuff.TXT Intervention', 'description': 'Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.\n\nSGR: 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.'}, {'id': 'OG001', 'title': 'Enough Snuff Intervention', 'description': 'Participants in this arm will be given the Enuff Snuff cessation manual.\n\nControl: 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.3', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '6.3', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '5.8', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6624', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1057', 'ciLowerLimit': '-0.5808', 'ciUpperLimit': '0.3693', 'pValueComment': 'P-value above is for the treatment-by-time squared term in the statistical model for longitudinal data; quadratic change in outcome determined, compared trajectory of outcome change in EnufSnuff (SGR) compared to Enough Snuff (control)', 'estimateComment': 'Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).', 'groupDescription': '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.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Multi-level, mixed-effects model for longitudinal data was conducted.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 6 months post-randomization', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '#EnufSnuff.TXT Intervention', 'description': 'Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.\n\nSGR: 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.'}, {'id': 'OG001', 'title': 'Enough Snuff Intervention', 'description': 'Participants in this arm will be given the Enuff Snuff cessation manual.\n\nControl: 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.0946', 'ciLowerLimit': '-0.0609', 'ciUpperLimit': '0.2501', 'pValueComment': 'A multi-level, mixed-effects model for longitudinal data was applied. The p-value provided above was for the treatment-by-time effect used to test for differences in the trajectory of change in craving reduction between the two treatment groups.', 'estimateComment': 'Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).', 'groupDescription': '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.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Multi-level, mixed-effects model for longitudinal data was conducted. (trajectory analysis)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 6 months post-randomization', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '#EnufSnuff.TXT Intervention', 'description': 'Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.\n\nSGR: 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.'}, {'id': 'FG001', 'title': 'Enough Snuff Intervention', 'description': 'Participants in this arm will be given the Enuff Snuff cessation manual.\n\nControl: 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '91'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '#EnufSnuff.TXT Intervention', 'description': 'Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.\n\nSGR: 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.'}, {'id': 'BG001', 'title': 'Enough Snuff Intervention', 'description': 'Participants in this arm will be given the Enuff Snuff cessation manual.\n\nControl: 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '45.1', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '44.9', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-28', 'size': 686804, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-16T11:55', 'hasProtocol': True}, {'date': '2022-01-28', 'size': 125743, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-16T11:55', 'hasProtocol': False}, {'date': '2022-01-28', 'size': 178949, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-11T13:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 532}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2020-03-18', 'resultsFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2020-03-18', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-16', 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit)', 'timeFrame': '6 months post-randomization', 'description': '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".'}], 'secondaryOutcomes': [{'measure': 'Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS)', 'timeFrame': 'Baseline, 3 months, and 6 months post-randomization', 'description': '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.'}, {'measure': 'Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ)', 'timeFrame': 'Baseline, 3 months, and 6 months post-randomization', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smokeless tobacco', 'quitting smokeless tobacco'], 'conditions': ['Smokeless Tobacco Cessation']}, 'referencesModule': {'references': [{'pmid': '39030750', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nGroup 2: Enough Snuff Intervention group\n\nParticipants 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.\n\nEnd 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) 18 years of age and older\n* 2\\) Have used smokeless tobacco for the last year, currently dip 3 or more times a day\n* 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\n* 4\\) Interested in participating in a cessation program; and\n* 5\\) Have access to a cell phone with unlimited texting ability.\n\nExclusion Criteria:\n\n* 1\\) Non-English speaking;\n* 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\n* 3\\) Currently participating in a smokeless tobacco cessation study.'}, 'identificationModule': {'nctId': 'NCT04315506', 'briefTitle': 'A Text-based Reduction Intervention for Smokeless Tobacco Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Text-based Reduction Intervention for Smokeless Tobacco Cessation', 'orgStudyIdInfo': {'id': 'Pro00103410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '#EnufSnuff.TXT Intervention', 'description': 'Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.', 'interventionNames': ['Behavioral: #EnufSnuff.TXT Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enough Snuff Intervention', 'description': 'Participants in this arm will be given the Enuff Snuff cessation manual.', 'interventionNames': ['Behavioral: Enough Snuff Intervention']}], 'interventions': [{'name': '#EnufSnuff.TXT Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['#EnufSnuff.TXT Intervention']}, {'name': 'Enough Snuff Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Enough Snuff Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Devon Noonan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}