Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-04-11 @ 8:10 PM
Study NCT ID:
NCT00109135
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2005-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers (0364-007)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521311', 'term': 'N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2005-04-22', 'studyFirstSubmitQcDate': '2005-04-22', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels', 'timeFrame': 'after 8 weeks of treatment'}]}, 'conditionsModule': {'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '20191360', 'type': 'DERIVED', 'citation': 'Morrison MF, Ceesay P, Gantz I, Kaufman KD, Lines CR. Randomized, controlled, double-blind trial of taranabant for smoking cessation. Psychopharmacology (Berl). 2010 Apr;209(3):245-53. doi: 10.1007/s00213-010-1790-2. Epub 2010 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoking greater than/equal to 10 cigarettes/day for at least 1 year\n* Laboratory tests that meet the criteria of the study\n* In overall good health as determined by the investigator\n\nExclusion Criteria:\n\n* Psychiatric diagnoses\n* Certain cancers\n* Patients who use nicotine replacement therapy\n* Patients on a diet regimen'}, 'identificationModule': {'nctId': 'NCT00109135', 'briefTitle': 'A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers (0364-007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Multicenter, Randomized, Titrated-Dose, Placebo-Controlled, Study of MK0364 (4 mg to 8 mg) in Chronic Cigarette Smokers as an Aid for Smoking Cessation', 'orgStudyIdInfo': {'id': '0364-007'}, 'secondaryIdInfos': [{'id': '2005_012'}, {'id': 'MK-0364-007'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'taranabant', 'type': 'DRUG', 'otherNames': ['MK0364']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}