Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-08 @ 3:05 AM
Study NCT ID:
NCT06586034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Smoking Treatment for Hispanic Individuals Who Smoke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-Day Point Prevalence Smoking Abstinence', 'timeFrame': 'End of treatment (Week 8)', 'description': '7-day point prevalence smoking status (verification via carbon monoxide).'}], 'secondaryOutcomes': [{'measure': 'Anxiety Sensitivity', 'timeFrame': 'Baseline, week 4, and end of treatment (Week 8)', 'description': 'Anxiety sensitivity will be assessed using the Short Scale Anxiety Sensitivity Index (SSASI).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile App', 'Smoking Cessation', 'Hispanic/Latino'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The specific aims of the project are to develop and test a mobile application for smoking cessation for Hispanic individuals who smoke called Impacto.', 'detailedDescription': 'A total of 56 Hispanic individuals who smoke will be recruited for this project. Six (6) participants will complete usability/functionality testing of Impacto 2.0 in the English language for both iOS and Android. Following usability/functionality testing, a field test with 50 adult Hispanic individuals who smoke (50% English-speaking and 50% Spanish-speaking) will be recruited nationally and will receive Impacto 2.0 (50% Android and iOS platforms).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) being Hispanic, 2) at least 18 years of age, 2) currently smoking (i.e., at least 5 cigarettes/day) biochemically verified by a CO \\> 7, 3), meeting criteria for high AS (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index), 4) motivation to quit \\> 5 on a 10 pt. scale, 5) able to provide informed consent, 6) has daily access to their own iPhone or Android smartphone, and 7) is a fluent English or Spanish speaker.\n\nExclusion Criteria:\n\n* 1\\) current participation in substance abuse treatment, 2) in psychotherapy for anxiety or depression, 3) concurrent use of medication for anxiety or depression, 4) active suicidality (ideation, intent, and/or plan), or 5) current psychosis.'}, 'identificationModule': {'nctId': 'NCT06586034', 'briefTitle': 'Mobile Smoking Treatment for Hispanic Individuals Who Smoke', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Culturally-Adapted Smoking Cessation Mobile App for Hispanic Individuals Who Smoke', 'orgStudyIdInfo': {'id': 'STUDY00004990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Impacto', 'description': 'This is the mobile application to be developed and evaluated in this project.', 'interventionNames': ['Behavioral: Impacto (Mobile App)']}], 'interventions': [{'name': 'Impacto (Mobile App)', 'type': 'BEHAVIORAL', 'description': 'This is the mobile app to be developed and evaluated in this project. It is designed for both English and Spanish languages and is culturally tailored for Hispanic/Latino/Latinx individuals who smoke. Impacto will be developed for both iOS and Android platforms. The mobile app aims to aid smoking cessation by targeting elevated anxiety sensitivity.', 'armGroupLabels': ['Impacto']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Justin M Shepherd, PhD', 'role': 'CONTACT', 'email': 'jmsheph4@central.uh.edu', 'phone': '713-743-8056'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hugh Roy and Lillie Cranz Cullen Distinguished University Professor', 'investigatorFullName': 'Michael J. Zvolensky, Ph.D.', 'investigatorAffiliation': 'University of Houston'}}}}