Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-07 @ 10:36 PM
Study NCT ID:
NCT00571805
Status:
WITHDRAWN
Last Update Posted:
2015-04-09
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2007-12-11', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking reward', 'timeFrame': 'laboratory test'}], 'secondaryOutcomes': [{'measure': '1 week abstinence induced craving and reward', 'timeFrame': 'Day 8, 9, 11 and 14 questionaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cigarette', 'craving', 'reward'], 'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 10 cigarettes/day\n* Interest in quitting smoking\n* Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test\n\nExclusion Criteria:\n\n* Pregnancy\n* Axis I psychiatric disorder which require treatment with psychoactive medication and would make study compliance difficult.\n* Clinically significant medical condition in opinion of study clinician\n* Drug or alcohol dependence inlast 12 months\n* Use of other smoking cessation medications ot treatment progams in last 2 months'}, 'identificationModule': {'nctId': 'NCT00571805', 'acronym': 'VarenSmoke', 'briefTitle': 'Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement', 'orgStudyIdInfo': {'id': 'Varenicline/Smoking'}, 'secondaryIdInfos': [{'id': 'GA30513U'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Varenicline', 'interventionNames': ['Drug: varencline']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'varencline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': '2.0 mg/day varencline (1.0 mg BID)', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'VA New York Harbor Healthcare System, MHAD clinic', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Malcolm Reid, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Malcolm S. Reid, PhD', 'oldOrganization': 'New York University School of Medicine'}}}}