Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02968095
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Text Message Support to Prevent Smoking Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-Day Point Prevalence Abstinence', 'timeFrame': 'End of Treatment (6-week) Follow-Up', 'description': 'Point prevalence abstinence is defined as the prevalence of not experiencing a full relapse in the period immediately preceding measurement. A full relapse will be defined as 7 continuous days of smoking or smoking ≥ 1 day(s) per week for the two consecutive weeks preceding the time of measurement. Self-reported abstinence will be verified by a Carbon Monoxide assay of breath samples and will override self-report in the direction of smoking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to test a text message intervention for people who are beginning an attempt to quit smoking. The intervention seeks to teach people to think about their cravings to smoke in more helpful ways. The investigators expect that participants receiving the text message craving program will be less likely to begin smoking again compared to participants in a control condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for at least 3 months. During the first visit smoking status will be verified by a Carbon Monoxide level of at least 8 parts per million.\n* Have a mobile phone and use text messaging at least monthly\n* Be planning to quit smoking without pharmacological help.\n\nExclusion Criteria:\n\n* Significant cognitive impairment\n* Current therapy or pharmacological intervention for smoking or nicotine cravings\n* Inability to read English'}, 'identificationModule': {'nctId': 'NCT02968095', 'briefTitle': 'Text Message Support to Prevent Smoking Relapse', 'organization': {'class': 'OTHER', 'fullName': 'Miami University'}, 'officialTitle': 'Text Message Support to Prevent Smoking Relapse in Community Treatment Settings', 'orgStudyIdInfo': {'id': 'K23DA037320', 'link': 'https://reporter.nih.gov/quickSearch/K23DA037320', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23DA037320', 'link': 'https://reporter.nih.gov/quickSearch/K23DA037320', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text Message Craving Program', 'description': 'Text messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day.', 'interventionNames': ['Behavioral: Text Message Craving Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-Help Manual Plus Control Texts', 'description': 'A print, self-help manual plus general motivational text messages delivered 2-3 times per day.', 'interventionNames': ['Behavioral: Self-Help Manual Plus Control Texts']}], 'interventions': [{'name': 'Text Message Craving Program', 'type': 'BEHAVIORAL', 'description': 'Text messages targeting cravings delivered 2-3 times per day.', 'armGroupLabels': ['Text Message Craving Program']}, {'name': 'Self-Help Manual Plus Control Texts', 'type': 'BEHAVIORAL', 'description': 'Self-help manual plus motivational text messages delivered 2-3 times per day.', 'armGroupLabels': ['Self-Help Manual Plus Control Texts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45056', 'city': 'Oxford', 'state': 'Ohio', 'country': 'United States', 'facility': 'Miami University', 'geoPoint': {'lat': 39.507, 'lon': -84.74523}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miami University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}