Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-26 @ 7:06 PM
Study NCT ID:
NCT00625794
Status:
COMPLETED
Last Update Posted:
2008-02-28
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotine Replacement and Counseling In Adolescents
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-27', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-27', 'lastUpdatePostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the Nicotine Nasal Spray by Adolescents.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 15 and 18 years-old\n* Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.\n\nExclusion Criteria:\n\n* Adolescents who were using or had used nicotine replacement in the prior week were excluded.\n* Those who used bupropion (Zyban®) within the past 30 days were also excluded.'}, 'identificationModule': {'nctId': 'NCT00625794', 'briefTitle': 'Nicotine Replacement and Counseling In Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers', 'orgStudyIdInfo': {'id': '1K23RR018471', 'link': 'https://reporter.nih.gov/quickSearch/1K23RR018471', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1K23RR018471', 'link': 'https://reporter.nih.gov/quickSearch/1K23RR018471', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '8 weeks or counseling plus 6 weeks of nicotine nasal spray', 'interventionNames': ['Drug: Nicotine nasal spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '8 weeks or counseling only.', 'interventionNames': ['Behavioral: Smoking cessation counseling']}], 'interventions': [{'name': 'Nicotine nasal spray', 'type': 'DRUG', 'description': '8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).', 'armGroupLabels': ['1']}, {'name': 'Smoking cessation counseling', 'type': 'BEHAVIORAL', 'description': '8 weeks or counseling', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Mark Rubinstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mark Rubinstein, MD', 'oldOrganization': 'UCSF'}}}}