Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-09 @ 6:25 AM
Study NCT ID:
NCT00888459
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2009-04-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study Evaluating Nicotine Lozenges and Self Help
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ebbert.jon@mayo.edu', 'phone': '507-266-1944', 'title': 'Jon O. Ebbert', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': '4 mg nicotine lozenges', 'otherNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Tobacco Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': '4 mg nicotine lozenges'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.432', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': '4 mg nicotine lozenges'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The first person was pre-screened on 05/20/08 and the last person was randomized on 09/29/08.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active', 'description': '4 mg nicotine lozenges'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '43.0', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smokeless tobacco', 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '3.8', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cans/week', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2009-04-24', 'resultsFirstSubmitDate': '2010-10-04', 'studyFirstSubmitQcDate': '2009-04-24', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-04', 'studyFirstPostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Tobacco Abstinence', 'timeFrame': '12 weeks', 'description': 'self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tobacco', 'chew', 'nrt', 'nicotine lozenges', 'self-help'], 'conditions': ['Smokeless Tobacco Use']}, 'referencesModule': {'references': [{'pmid': '20060229', 'type': 'RESULT', 'citation': 'Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users. Addict Behav. 2010 May;35(5):522-5. doi: 10.1016/j.addbeh.2009.12.020. Epub 2010 Jan 4.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.', 'detailedDescription': 'Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male;\n2. ≥18 years of age;\n3. report ST as their primary tobacco of use;\n4. have used ST daily for the past 6 months;\n5. indicate that they want to quit;\n6. have been provided with, understand, and have signed the informed consent.\n\nExclusion Criteria:\n\n1. previously enrolled in a study involving the use of the nicotine lozenge;\n2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;\n3. currently enrolled in another research study;\n4. describe having a medical history of: a) unstable angina; b) myocardial infarction within the past 6 months; c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;\n5. have phenylketonuria (PKU) \\[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\\];\n6. have another member of their household already participating in this study;\n7. have other medical or psychiatric conditions that would exclude the participant;\n8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.'}, 'identificationModule': {'nctId': 'NCT00888459', 'briefTitle': 'A Pilot Study Evaluating Nicotine Lozenges and Self Help', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users', 'orgStudyIdInfo': {'id': '07-008574'}, 'secondaryIdInfos': [{'id': 'CA121165'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active', 'description': 'Self-help counseling material and 4 mg nicotine lozenges', 'interventionNames': ['Drug: nicotine replacement therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'self help counseling material and placebo nicotine lozenges', 'interventionNames': ['Drug: placebo NRT']}], 'interventions': [{'name': 'nicotine replacement therapy', 'type': 'DRUG', 'otherNames': ['Nicotine Lozenges'], 'description': '4 mg nicotine lozenges, ad lib, for 12 weeks.', 'armGroupLabels': ['active']}, {'name': 'placebo NRT', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'Placebo nicotine lozenges', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '97403', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Research Institute', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Jon O Ebbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jon Ebbert, MD', 'oldOrganization': 'Mayo Clinic'}}}}