Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-28 @ 11:18 PM
Study NCT ID:
NCT00633256
Status:
COMPLETED
Last Update Posted:
2012-04-11
First Post:
2008-02-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}, {'id': 'D013619', 'term': 'Tacrine'}, {'id': 'D007538', 'term': 'Isoniazid'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000609', 'term': 'Aminoacridines'}, {'id': 'D000166', 'term': 'Acridines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.poling@yale.edu', 'phone': '203-937-4830', 'title': 'James Poling, Ph.D.', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cycloserine', 'description': '50 mg cycloserine', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matched placebo', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycloserine', 'description': '50 mg cycloserine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week follow-up', 'description': 'The number of cigarettes smoked per day at the 1 week follow up time point.', 'unitOfMeasure': 'Cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants used for analysis were those who completed the 4-week follow-up timepoint.'}, {'type': 'SECONDARY', 'title': 'Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycloserine', 'description': '50 mg cycloserine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Week Followup', 'description': 'The number of cigarettes smoked per day at the 4-week follow up timepoint.', 'unitOfMeasure': 'Cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the study at the 4-week timepoint.'}, {'type': 'SECONDARY', 'title': 'Urinary Cotinine Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycloserine', 'description': '50 mg cycloserine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1645.5', 'spread': '1180.8', 'groupId': 'OG000'}, {'value': '2062.6', 'spread': '1091.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Week Follow-up Timepoint', 'description': 'Urinary Cotinine level at the 4-week follow up timepoint', 'unitOfMeasure': 'Mean ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects used for analysis are those who reached the 4 week followup timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cycloserine', 'description': '50 mg cycloserine'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matched placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cycloserine', 'description': '50 mg cycloserine'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matched placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '41.5', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2008-02-29', 'resultsFirstSubmitDate': '2012-03-14', 'studyFirstSubmitQcDate': '2008-03-10', 'lastUpdatePostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-14', 'studyFirstPostDateStruct': {'date': '2008-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cigarettes Smoked Per Day', 'timeFrame': '1 week follow-up', 'description': 'The number of cigarettes smoked per day at the 1 week follow up time point.'}], 'secondaryOutcomes': [{'measure': 'Cigarettes Smoked Per Day', 'timeFrame': '4 Week Followup', 'description': 'The number of cigarettes smoked per day at the 4-week follow up timepoint.'}, {'measure': 'Urinary Cotinine Level', 'timeFrame': '4 Week Follow-up Timepoint', 'description': 'Urinary Cotinine level at the 4-week follow up timepoint'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '19592176', 'type': 'BACKGROUND', 'citation': 'Santa Ana EJ, Rounsaville BJ, Frankforter TL, Nich C, Babuscio T, Poling J, Gonsai K, Hill KP, Carroll KM. D-Cycloserine attenuates reactivity to smoking cues in nicotine dependent smokers: a pilot investigation. Drug Alcohol Depend. 2009 Oct 1;104(3):220-7. doi: 10.1016/j.drugalcdep.2009.04.023. Epub 2009 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'A total of 20 subjects will participate in this four week, between groups, double-blind, placebo controlled study. Subjects will participate in two experimental sessions separated by approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or placebo combined with cue exposure. Several physiological and subjective outcome measures (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions lasting approximately thirty minutes. Our aims are:\n\n1. To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity in overnight abstinent smokers. Reactivity to smoking cues will be captured with self-report smoking urges and physiological measures (heart rate, blood pressure, and skin conductance).\n\n We hypothesize that cycloserine, relative to placebo, will facilitate extinction of smoking cue reactivity.\n2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking behavior will be measured with self-report smoking and saliva cotinine levels.\n3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine dependent smokers. Memory performance will be measured with verbal learning, recognition and recall tasks.\n\n4\\) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female and male smokers, aged 18 to 55 years;\n* history of smoking daily for the past 12 months, at least 10 cigarettes daily;\n* CO level \\> 10ppm;\n* for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods other than OCP;\n* Non-treatment seeking nicotine dependent smokers.\n\nExclusion Criteria:\n\n* history of heart disease, renal or hepatic diseases or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;\n* regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and/or recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year;\n* current dependence on alcohol or on drugs other than nicotine;\n* regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;\n* allergy to cycloserine;\n* subjects with epilepsy or a history of seizures;\n* Treatment seeking nicotine dependent smokers.'}, 'identificationModule': {'nctId': 'NCT00633256', 'briefTitle': 'The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers.', 'orgStudyIdInfo': {'id': '0601001031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cycloserine', 'description': '50 mg cycloserine', 'interventionNames': ['Drug: Cycloserine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cycloserine', 'type': 'DRUG', 'otherNames': ['Closina Aspen, Austral.', 'Cycloserine Capsules USP 29', 'Cycloserine (TM)King, UK', 'D-cycloserin IFET (IFET), Gr.', 'Proserine Hawon, Thai.', 'Seromycin - 250 MG - Capsule Dura Pharmaceuticals', 'Seromycin - 250 MG - Oral Capsule Eli Lilly', 'Seromycin (FM) Lilly, Canad.', 'Seromycin Dura, USA', 'Seromycin Lilly, Hong Kong', 'Seromycin With Isoniazid - 250 MG - Capsule Eli Lilly', 'Siklocap'], 'description': '50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.', 'armGroupLabels': ['Cycloserine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'West Haven VA', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'James Poling, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'VA Connecticut Healthcare System', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'James Poling', 'investigatorAffiliation': 'Yale University'}}}}