Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT01368016
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2011-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2011-06-06', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC): Urges to Smoke-vs-Time', 'timeFrame': 'During 5 hours post-dose', 'description': 'Area under urges to smoke-vs.-time curve'}], 'secondaryOutcomes': [{'measure': 'Amount of Nicotine Released', 'timeFrame': '30 minutes', 'description': 'The amount of nicotine released during product administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Nicotine Pharmacodynamics'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.', 'detailedDescription': 'This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.\n\nThe subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.\n\nElectronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.\n* Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.\n* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.\n* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Pregnancy, lactation or intended pregnancy.\n* Treatment with an investigational product within one month preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT01368016', 'briefTitle': 'Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers', 'orgStudyIdInfo': {'id': 'NICTDP2012'}, 'secondaryIdInfos': [{'id': '2010-023268-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental NRT', 'description': 'A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits.', 'interventionNames': ['Drug: Nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine GUM', 'description': 'A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits.', 'interventionNames': ['Drug: Nicotine']}], 'interventions': [{'name': 'Nicotine', 'type': 'DRUG', 'otherNames': ['Not yet marketed'], 'description': 'A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits', 'armGroupLabels': ['Experimental NRT']}, {'name': 'Nicotine', 'type': 'DRUG', 'otherNames': ['Nicorette® Freshfruit gum'], 'description': 'A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits', 'armGroupLabels': ['Nicotine GUM']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-222 20', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Clinical Pharmacology, McNeil AB', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'SE-141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Trial Alliance (KTA), University Hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Elisabeth Kruse, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McNeil AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McNeil AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}