Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-30 @ 4:09 PM
Study NCT ID:
NCT06891235
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oral Fluid Testing Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Within-day frequency of cannabis use', 'timeFrame': 'Day-12 visit', 'description': 'Number of times cannabis used within each day included in the intervals being examined for agreement (Specific Aim 2A and 2B), reported on TLFB calendar interview'}, {'measure': 'Timing of cannabis use', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': 'Number of hours between last use and oral fluid testing time'}], 'primaryOutcomes': [{'measure': 'Testing duration: self-testing', 'timeFrame': 'Across 6 days leading up to the Day-12 visit', 'description': 'Duration in minutes of videos of self-testing'}, {'measure': 'Testing duration: observed test', 'timeFrame': 'Day of/During the Day-12 visit', 'description': 'Duration in minutes of observed self-testing during study visit'}, {'measure': 'Oral fluid testing protocol adherence: self-testing completed', 'timeFrame': 'Across 6 days leading up to the Day-12 visit', 'description': 'Number and percent of videos of self-testing completed'}, {'measure': 'Oral fluid testing protocol adherence: observed test completed', 'timeFrame': 'Day of/During the Day-12 visit', 'description': 'Number and percent of live self-testing completed'}, {'measure': 'Oral fluid testing protocol adherence: testing steps performed', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': 'Number and percent of each step of self-testing performed (yes/no)'}, {'measure': 'Oral fluid testing protocol adherence: testing steps performed correctly', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': 'Number and percent of each step of self-testing performed correctly (yes/no)'}, {'measure': 'Unreadable test results', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': 'Number and percent of oral fluid tests with unreadable results'}, {'measure': 'Inconclusive test results', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': 'Number and percent of oral fluid tests with inconclusive results'}, {'measure': 'Oral fluid test results', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': 'Oral fluid test results for delta-9- tetrahydrocannabinol (delta-9-THC) on day of test (negative = non-use / positive = use)'}, {'measure': 'Oral fluid acceptability', 'timeFrame': 'Day-12 visit', 'description': 'Measure of acceptability (usability, likability, burden), 5 items, 5-point Likert-type scale (1, Strongly Disagree to 5, Strongly Agree), with higher score indicating greater acceptability.\n\nBenchmark for scale: ≥80% of participants with mean item score ≥4 out of 5'}, {'measure': 'Use/Non-use intervals of 4 days', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': "Agreement between oral fluid results for 3 consecutive days (any positive = use / all negative = non-use) and self-report on timeline follow-back (TLFB) calendar interview for the same 3 days plus 1 day earlier (any days of use = use / no days of use = non-use).\n\nBenchmark: ≥ moderate agreement (Cohen's kappa ≥ 0.6)"}, {'measure': 'Use/Non-use', 'timeFrame': 'Day-12 visit', 'description': "Agreement between oral fluid test results (positive/negative) and urine test result (positive/negative).\n\nBenchmarks: strong agreement (Cohen's kappa ≥ 0.8) for use; weak agreement (Cohen's kappa \\< 0.6) for non-use"}], 'secondaryOutcomes': [{'measure': 'Use/Non-use for intervals of 2-8 days', 'timeFrame': 'Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit', 'description': 'Agreement (use/non-use) between oral fluid test results and cannabis use reported on TLFB calendar interview for corresponding intervals ranging from 2 days (day of and day before testing, ≤24 hours prior) to 8 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cannabis use', 'young adult', 'oral fluid testing'], 'conditions': ['Cannabis Use', 'Cannabis Intoxication', 'Cannabis Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\\~Day 3; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\\~Day 12; TLFB interview, urine test, oral fluid test, survey, interview).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 30 years\n* Cannabis use on \\>=1x/week in the past 30 days\n* Ownership of a portable device that is capable of videoconference and videorecording (i.e., smartphone, tablet computer, or laptop computer)\n* Ability to read and speak English\n* Availability for duration of the study (2-3 weeks).\n* To proceed to oral fluid testing, positive result for urinary TCH-COOH\n\nExclusion Criteria:\n\n• Inability/unwillingness to provide contact information'}, 'identificationModule': {'nctId': 'NCT06891235', 'acronym': 'SOFTA', 'briefTitle': 'Study of Oral Fluid Testing Approach', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials', 'orgStudyIdInfo': {'id': 'IRB-P00050265'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective community sample', 'description': 'Community sample of 200 younger adults aged 18-30 years who have used cannabis in the past 30 days, report use frequency of ≥1x/week, and have a positive test for urinary 11-nor-9-carboxy-delta-9-tetrocannabinol (THC-COOH) at baseline', 'interventionNames': ['Other: Biologic testing for THC']}], 'interventions': [{'name': 'Biologic testing for THC', 'type': 'OTHER', 'description': 'Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.', 'armGroupLabels': ['Prospective community sample']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lydia A. Shrier, MD, MPH', 'role': 'CONTACT', 'email': 'lydia.shrier@childrens.harvard.edu', 'phone': '617-355-8306'}, {'name': 'Lydia A. Shrier, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Lydia A Shrier, MD, MPH', 'role': 'CONTACT', 'email': 'lydia.shrier@childrens.harvard.edu', 'phone': '(617) 355-8306'}, {'name': 'Sion K Harris, PhD, RN', 'role': 'CONTACT', 'email': 'sion.harris@childrens.harvard.edu', 'phone': '857-218-4304'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'De-identified scientific data will be shared as soon as possible. De-identified scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified survey data and biologic test result data', 'accessCriteria': 'De-identified scientific data and metadata arising from the project will be archived in the openICPSR repository. De-identified scientific data from this project will be findable through summary information (metadata) that will be readily available on the Center for Adolescent Behavioral Health Research website, the repository website, and clinicaltrials.gov.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Lydia Shrier', 'investigatorAffiliation': "Boston Children's Hospital"}}}}