Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00440505
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2007-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Nicotine on Chronic Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pdf3@columbia.edu', 'phone': '212-305-2008', 'title': 'Pamela Flood, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Non-smokers with the placebo patch', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotine 5mg', 'description': 'Non-smokers with the Nicotine 5mg patch', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nicotine 10mg', 'description': 'Non-smokers with the Nicotine 10mg patch', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG001', 'title': 'Nicotine 5 mg', 'description': 'Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG002', 'title': 'Nicotine 10 mg', 'description': 'Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '3.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.'}, {'type': 'SECONDARY', 'title': 'Patient Self-assessment of Psychological Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG001', 'title': 'Nicotine 5 mg', 'description': 'Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG002', 'title': 'Nicotine 10 mg', 'description': 'Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '37.5', 'spread': '18.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reported an Increase in Daily Pain Medication Regime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG001', 'title': 'Nicotine 5 mg', 'description': 'Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG002', 'title': 'Nicotine 10 mg', 'description': 'Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG001', 'title': 'Nicotine 5 mg', 'description': 'Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}, {'id': 'OG002', 'title': 'Nicotine 10 mg', 'description': 'Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg', 'description': 'Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.'}, {'id': 'FG001', 'title': 'Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg', 'description': 'Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.'}, {'id': 'FG002', 'title': 'Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo', 'description': 'Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.'}, {'id': 'FG003', 'title': 'Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg', 'description': 'Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.'}, {'id': 'FG004', 'title': 'Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo', 'description': 'Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.'}, {'id': 'FG005', 'title': 'Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg', 'description': 'Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This double-blind prospective study was approved by the Institutional Review Board of Columbia University Medical Center. Written consent was obtained from all subjects. Women presenting with chronic pelvic pain to a gynecologist or to the pain clinic at New York Presbyterian Hospital were eligible for inclusion.', 'preAssignmentDetails': 'Twenty-six women were recruited for the study. Six women declined to participate after consenting but before commencing treatment; these women are not included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2007-02-26', 'resultsFirstSubmitDate': '2010-10-01', 'studyFirstSubmitQcDate': '2007-02-26', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-01-12', 'studyFirstPostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': '1 day', 'description': 'Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.'}], 'secondaryOutcomes': [{'measure': 'Patient Self-assessment of Psychological Distress', 'timeFrame': '1 day', 'description': 'Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.'}, {'measure': 'Number of Participants Who Reported an Increase in Daily Pain Medication Regime', 'timeFrame': '1 day', 'description': 'Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.'}, {'measure': 'Nausea', 'timeFrame': '1 day', 'description': 'Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic pain', 'pelvic pain', 'nicotine patch'], 'conditions': ['Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.', 'detailedDescription': 'Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, 5mg, and 10mg) administered in a random order; the study is double-blinded and patients act as their own controls. Subjects apply the placebo or nicotine patches in the morning and remove them in the evening when they fill out a pain diary for the day. During the study, patients will continue their typical course of pain medication and report pain medication use in the pain diary.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pelvic pain\n* Aged 18-60 years\n* Female\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Cardiovascular disease\n* Current analgesic abuse\n* Pregnancy\n* Current usage of nicotine patch or gum\n* Allergy to adhesive tape'}, 'identificationModule': {'nctId': 'NCT00440505', 'briefTitle': 'Effect of Nicotine on Chronic Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Effect of Nicotine on Chronic Pelvic Pain', 'orgStudyIdInfo': {'id': 'AAAA4808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine (5 mg)', 'description': 'Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.', 'interventionNames': ['Drug: Nicotine (5 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine (10 mg)', 'description': 'Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.', 'interventionNames': ['Drug: Nicotine (10 mg)']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.', 'armGroupLabels': ['Placebo']}, {'name': 'Nicotine (5 mg)', 'type': 'DRUG', 'description': 'Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.', 'armGroupLabels': ['Nicotine (5 mg)']}, {'name': 'Nicotine (10 mg)', 'type': 'DRUG', 'description': 'Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.', 'armGroupLabels': ['Nicotine (10 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pamela Flood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Jessamyn Conell-Price, BA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Pamela Flood', 'investigatorAffiliation': 'Columbia University'}}}}