Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 7:16 AM
Study NCT ID:
NCT06822569
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teen Health Choices & Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum subjective craving during cannabis cue exposure (rated on a 0 to 10 scale).', 'timeFrame': 'Baseline, 1 year, 2 years', 'description': 'This study utilizes a structured cannabis cue exposure paradigm. During cue exposure, participants rate subjective craving on a scale from 0, "Not at all," to 10, "Extremely." The specific item to assess positive effects is the question, "How strong is your craving to use cannabis right now" sourced from the Morean\' Drug Craving Questionnaire-Now. See reference section.'}], 'secondaryOutcomes': [{'measure': 'Maximum subjective positive effects of cannabis use in daily life (rated on a 0 to 10 scale).', 'timeFrame': 'Baseline, 1 year, 2 years', 'description': 'This study utilizes a smartphone application to collect self-reported subjective cannabis effects in the participant\'s daily life. Following a self-initiated report of cannabis use in daily life, participants rate subjective positive effects of cannabis at that moment (i.e., "right now") on a scale from 0, "Not at all," to 10, "Extremely." The specific item to assess positive effects is the question, "Do you like any of the effects you are feeling right now?" sourced from the Tiffany\'s Drug Effects Questionnaire. See reference section.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Behavior', 'Wellness, Psychological', 'Substance Use']}, 'referencesModule': {'references': [{'pmid': '23271193', 'type': 'BACKGROUND', 'citation': "Morean ME, de Wit H, King AC, Sofuoglu M, Rueger SY, O'Malley SS. The drug effects questionnaire: psychometric support across three drug types. Psychopharmacology (Berl). 2013 May;227(1):177-92. doi: 10.1007/s00213-012-2954-z. Epub 2012 Dec 28."}, {'pmid': '8174499', 'type': 'BACKGROUND', 'citation': 'Tiffany ST, Singleton E, Haertzen CA, Henningfield JE. The development of a cocaine craving questionnaire. Drug Alcohol Depend. 1993 Dec;34(1):19-28. doi: 10.1016/0376-8716(93)90042-o.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. be age 13 to 16 years\n2. engage in a target health behavior on at least one recent occasion\n3. speak, read, and understand English or Spanish\n4. live in or near Rhode Island\n\nExclusion Criteria:\n\n1. lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder\n2. current psychotic symptoms or active suicidality (i.e., intent in the past 30 days)'}, 'identificationModule': {'nctId': 'NCT06822569', 'acronym': 'THC&W', 'briefTitle': 'Teen Health Choices & Wellness', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Teen Health Choices & Wellness', 'orgStudyIdInfo': {'id': '2023003584'}, 'secondaryIdInfos': [{'id': 'R01DA055600', 'link': 'https://reporter.nih.gov/quickSearch/R01DA055600', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Naturalistic, longitudinal', 'description': 'Teenagers ages 13 to 16 years at the time of recruitment.', 'interventionNames': ['Other: Cue reactivity paradigm']}], 'interventions': [{'name': 'Cue reactivity paradigm', 'type': 'OTHER', 'description': 'Participants will be exposed to cues in a fixed sequence while they answer questions about their emotions and thoughts. The cues will include everyday items (e.g., an ink pen) and substance-related items (e.g., a vape pen).', 'armGroupLabels': ['Naturalistic, longitudinal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Primary Researcher', 'role': 'CONTACT', 'email': 'teenhealth@brown.edu', 'phone': '401-863-6623'}, {'name': 'Project Coordinator', 'role': 'CONTACT', 'email': 'teenhealth@brown.edu', 'phone': '401-863-6670'}, {'name': 'Hayley T Padovano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brown University School of Public Health', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Primary Researcher', 'role': 'CONTACT', 'email': 'teenhealth@brown.edu', 'phone': '401-863-6623'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data that cannot individually identify participants may be shared with researchers internal and external to Brown University upon reasonable request by qualified research collaborators. Data shared with qualified researchers will not contain any protected health information or other personally identifiable information that could be used to identify individual participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}