Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT07301151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PASCAL Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of trial procedures', 'timeFrame': '1 day', 'description': 'The proportion of enrolled participants who download the study app'}, {'measure': 'Feasibility of study procedures', 'timeFrame': '2 weeks', 'description': 'The proportion of participants (among those who downloaded the app) who complete the week 2 post-quit visit'}, {'measure': 'Health Information Technology Usability Evaluation Scale (Health-ITUES)', 'timeFrame': '2 weeks', 'description': 'This scale will be used to access the acceptability of study app. The scale consists of 20 questions scored from 1 to 5 with higher values indicating more positive response'}], 'secondaryOutcomes': [{'measure': 'Average number of daily interactions with the study app', 'timeFrame': '2 weeks'}, {'measure': 'The average number of cigarettes smoked per day', 'timeFrame': '2 weeks'}, {'measure': 'Average number of nicotine lozenges used', 'timeFrame': '2 weeks'}, {'measure': 'The proportion of participants who complete the week 8 post-quit visit', 'timeFrame': '8 weeks'}, {'measure': 'The proportion of participants not smoking for the 7 day period before the week 2 visit', 'timeFrame': '2 weeks'}, {'measure': 'The proportion of participants not smoking for the 7 day period before the week 8 visits', 'timeFrame': '8 weeks'}, {'measure': 'The proportion of participants not smoking at all between the quit date and the week 2 visit', 'timeFrame': '2 weeks'}, {'measure': 'The proportion of participants not smoking at all between the quit date and the week 8 visit', 'timeFrame': '8 weeks'}, {'measure': 'Motivation to quit smoking', 'timeFrame': '2 weeks', 'description': 'Using a 1 - 10 scale on the contemplation to quit ladder (1 - no interest in quitting; 10 - will never smoke again)'}, {'measure': 'Brief Questionnaire of Smoking Urges (QSU-Brief)', 'timeFrame': '2 weeks', 'description': 'Questionnaire assessing craving severity. Range for total score is 10 - 70 with higher score indicating greater craving'}, {'measure': 'The Minnesota Nicotine Withdrawal Scale (MNWS)', 'timeFrame': '2 weeks', 'description': 'Questionnaire assessing withdrawal symptom severity. Range for total score is 0 - 36 with higher score indicating greater withdrawal symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cigarette smoking', 'chatbot'], 'conditions': ['Smoking Cessation', 'Smoking (Tobacco) Addiction']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized study is to assess if a conversational agent (or chatbot) that the investigators have developed to help with quitting smoking is acceptable to people trying to quit smoking and to also collect initial information regarding its effectiveness.\n\nIn this study, some participants trying to quit smoking will be provided with this chatbot while other participants will not be'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as Black or African American\n* Be at least 21 years of age\n* Meet a minimum smoking amount\n* Be willing to make a quit attempt in the next 30 days\n* Have a smartphone capable of downloading and running the study app\n* Be able to upload data from the app\n* Agree to receive text message reminders about study activities\n* Be a native English speaker\n* Reside in Minnesota.\n\nExclusion Criteria:\n\n* Medicinal nicotine use would require careful monitoring by a healthcare professional\n* Medical condition or medication used likely to significantly interfere with study outcomes or to be significantly affected by changes in smoking behavior\n* Are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07301151', 'briefTitle': 'PASCAL Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization', 'orgStudyIdInfo': {'id': 'STUDY00026782'}, 'secondaryIdInfos': [{'id': 'P50MD017342', 'link': 'https://reporter.nih.gov/quickSearch/P50MD017342', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chatbot assisted smoking trigger management', 'interventionNames': ['Other: chatbot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Other: no chatbot']}], 'interventions': [{'name': 'chatbot', 'type': 'OTHER', 'description': 'a chatbot will alert during predicted high risk smoking times and suggest approaches to manage potential smoking triggers', 'armGroupLabels': ['chatbot assisted smoking trigger management']}, {'name': 'no chatbot', 'type': 'OTHER', 'description': 'no chatbot is provided', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Sheena Study Coordinator', 'role': 'CONTACT', 'email': 'gahmx008@umn.edu', 'phone': '612-626-5981'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Non-identifiable data will be deposited into the University of Minnesota Data Repository (DRUM)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}