Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-09 @ 7:03 AM
Study NCT ID:
NCT01896518
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2013-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Methods to Reduce Children's Secondhand Smoke Exposure II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2013-06-20', 'studyFirstSubmitQcDate': '2013-07-10', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Child Salivary Cotinine', 'timeFrame': '3, 6, and 12 weeks', 'description': 'Child salivary cotinine will be measured to assess the level of secondhand smoke exposure. We will measure the change throughout the study.'}], 'secondaryOutcomes': [{'measure': 'Change in Parent and Child Lung Function', 'timeFrame': '3, 6, 12 weeks', 'description': 'We will collect both parent and child spirometry data and compare changes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['second hand smoke exposure; children'], 'conditions': ['Secondhand Smoke']}, 'descriptionModule': {'briefSummary': "The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be included in the study, participants must:\n\n1. be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more \\> 1 child between 3-11 years, we will include the youngest),\n2. smoke at least 10 cigarettes per day for the past year,\n3. indicate that they smoke around their child or in the car or home at least one time per week\\],\n4. have no intention of quitting smoking in the next 12-weeks,\n5. aged 18-65 years,\n6. be fluent in English,\n7. have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension),\n8. not currently pregnant, planning to become pregnant, or breastfeeding,\n9. do not use non-cigarette tobacco (cigars, chewing tobacco)\n10. have no prior use of any potential reduced exposure product,\n11. have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence\n\nExclusion Criteria:\n\nDoes not meet all of the requirements of inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01896518', 'acronym': 'EZII', 'briefTitle': "Novel Methods to Reduce Children's Secondhand Smoke Exposure II", 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': "Novel Methods to Reduce Children's Secondhand Smoke Exposure II", 'orgStudyIdInfo': {'id': '0642'}, 'secondaryIdInfos': [{'id': '1R21CA164521-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21CA164521-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Counseling'}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine lozenge', 'description': 'Participants will receive nicotine lozenge to use as needed for 12 weeks.', 'interventionNames': ['Drug: Nicotine polacrilex']}, {'type': 'EXPERIMENTAL', 'label': 'Tobacco lozenge', 'description': 'Participants will receive tobacco lozenge to use as needed for 12 weeks.', 'interventionNames': ['Drug: Tobacco lozenge']}], 'interventions': [{'name': 'Nicotine polacrilex', 'type': 'DRUG', 'armGroupLabels': ['Nicotine lozenge']}, {'name': 'Tobacco lozenge', 'type': 'DRUG', 'armGroupLabels': ['Tobacco lozenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "The Children's Hospital at OU Medical Center", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Theodore Wagener, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}