Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00458718
Status:
COMPLETED
Last Update Posted:
2009-04-20
First Post:
2007-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch
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': 'D000077285', 'term': 'Rimonabant'}], 'ancestors': [{'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 755}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-17', 'studyFirstSubmitDate': '2007-04-10', 'studyFirstSubmitQcDate': '2007-04-10', 'lastUpdatePostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements'}], 'secondaryOutcomes': [{'measure': 'Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence'}, {'measure': 'Safety data'}]}, 'conditionsModule': {'keywords': ['abstinence', 'nicotine patch'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '19149823', 'type': 'DERIVED', 'citation': 'Rigotti NA, Gonzales D, Dale LC, Lawrence D, Chang Y; CIRRUS Study Group. A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain. Addiction. 2009 Feb;104(2):266-76. doi: 10.1111/j.1360-0443.2008.02454.x.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit.\n\nSecondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokers smoking at least 15 cigarettes/day as a mean within the 2 months preceding the screening visit\n* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale\n\nExclusion Criteria:\n\n* non tobacco cigarettes consumption\n* chronic use of marijuana\n* pregnancy\n* breastfeeding\n* any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug\n* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change'}, 'identificationModule': {'nctId': 'NCT00458718', 'acronym': 'CIRRUS', 'briefTitle': 'Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Single Country, Double-Blind, Randomized, 2-Arm, Parallel-Group Study, Evaluating Efficacy and Safety of Rimonabant 20 mg OD, With/Without Association of Nicotine Patch, as Aid to Smoking Cessation During 9-Week Period', 'orgStudyIdInfo': {'id': 'EFC4798'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rimonabant (SR141716)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}