Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT00710034
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2008-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D040261', 'term': 'Harm Reduction'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014030', 'term': 'Tobacco, Smokeless'}, {'id': 'D000074164', 'term': 'Nicotine Chewing Gum'}], 'ancestors': [{'id': 'D062789', 'term': 'Tobacco Products'}, {'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hatsu001@umn.edu', 'phone': '612-626-2121', 'title': 'Dorothy Hatsukami, Ph.D.', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Subjects were provided study product for 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum', 'otherNumAtRisk': 195, 'otherNumAffected': 0, 'seriousNumAtRisk': 195, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus', 'otherNumAtRisk': 196, 'otherNumAffected': 0, 'seriousNumAtRisk': 196, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death', 'notes': 'Subject was diagnosed with leiomyosarcoma at week 6 in the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Hospitalization due to suicidal ideation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Product Effect on Complete Substitution for Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum'}, {'id': 'OG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 week post smoking substitution', 'description': 'Number of subjects using only the assigned study product at week 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Cigarettes Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum'}, {'id': 'OG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '28.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post cigarette substitution', 'description': 'Cigarettes per day at mid intervention', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Products Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum'}, {'id': 'OG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus'}], 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '24.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post smoking substitution', 'description': 'Pieces of product per week at mid intervention', 'unitOfMeasure': 'Pieces per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Products Effect on Withdrawal Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum'}, {'id': 'OG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus'}], 'classes': [{'title': 'Baseline Scores', 'categories': [{'measurements': [{'value': '4.17', 'spread': '5.01', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '5.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Scores', 'categories': [{'measurements': [{'value': '5.57', 'spread': '6.05', 'groupId': 'OG000'}, {'value': '5.73', 'spread': '6.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12 post switching', 'description': 'Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Using assigned product only. The numbers of subjects that were only using the assigned product were 40 and 37 for nicotine gum and oral tobacco respectively at week 12. Analysis was conducted from weeks 1-12 post-switching.'}, {'type': 'SECONDARY', 'title': 'Product Effect on Biomarkers of Exposure and Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum'}, {'id': 'OG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.39', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4 post smoking substitution', 'description': 'Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).', 'unitOfMeasure': 'pmol//mg creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum'}, {'id': 'FG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus'}], 'periods': [{'title': 'Completed 6 Weeks of Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 6 weeks of treatment for primary outcome assessment: N=154', 'groupId': 'FG000', 'numSubjects': '154'}, {'comment': 'Completed 6 weeks of treatment for primary outcome assessment: N=149', 'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Product dissatisfaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Completed 12 Weeks of Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Product Dissatisfaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Cigarette smokers interested in completely switching to snus or nicotine gum were recruited from Minneapolis/St Paul, Minnesota, and Eugene, Oregon.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotine Gum', 'description': 'Nicotine replacement therapy\n\nNicotine Gum: 4 mg Nicotine gum'}, {'id': 'BG001', 'title': 'Snus', 'description': 'Oral tobacco\n\nOral tobacco: Snus'}, {'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': '195', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '391', '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': '43.9', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This was an open label trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 391}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2008-07-02', 'resultsFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-31', 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Product Effect on Complete Substitution for Smoking', 'timeFrame': '6 week post smoking substitution', 'description': 'Number of subjects using only the assigned study product at week 6'}, {'measure': 'Number of Cigarettes Smoked', 'timeFrame': '6 weeks post cigarette substitution', 'description': 'Cigarettes per day at mid intervention'}, {'measure': 'Number of Products Used', 'timeFrame': '6 weeks post smoking substitution', 'description': 'Pieces of product per week at mid intervention'}], 'secondaryOutcomes': [{'measure': 'Products Effect on Withdrawal Symptoms.', 'timeFrame': 'Week 1-12 post switching', 'description': 'Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.'}, {'measure': 'Product Effect on Biomarkers of Exposure and Toxicity', 'timeFrame': 'Baseline and Week 4 post smoking substitution', 'description': 'Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral Tobacco Products', 'Snus', 'Smoking Substitution', 'Harm Reduction', 'Biomarkers of Tobacco Exposure'], 'conditions': ['Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '25991608', 'type': 'BACKGROUND', 'citation': 'Hatsukami DK, Severson H, Anderson A, Vogel RI, Jensen J, Broadbent B, Murphy SE, Carmella S, Hecht SS. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching. Tob Control. 2016 May;25(3):267-74. doi: 10.1136/tobaccocontrol-2014-052080. Epub 2015 May 19.'}]}, 'descriptionModule': {'briefSummary': 'For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.\n\nFor the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.', 'detailedDescription': 'This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoking at least 10 cigarettes daily for the past year,\n* in good physical health (no unstable medical condition;\n* no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).\n\nExclusion Criteria:\n\nSubjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT00710034', 'briefTitle': 'Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking', 'orgStudyIdInfo': {'id': '1R01 CA135884-2'}, 'secondaryIdInfos': [{'id': '1R01CA135884', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA135884', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Gum', 'description': 'Nicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.', 'interventionNames': ['Drug: Nicotine Gum']}, {'type': 'EXPERIMENTAL', 'label': 'Snus', 'description': 'Oral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.', 'interventionNames': ['Other: Oral tobacco']}], 'interventions': [{'name': 'Oral tobacco', 'type': 'OTHER', 'otherNames': ['Camel Snus'], 'description': 'Snus', 'armGroupLabels': ['Snus']}, {'name': 'Nicotine Gum', 'type': 'DRUG', 'otherNames': ['Nicorette'], 'description': '4 mg Nicotine gum', 'armGroupLabels': ['Nicotine Gum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '97403', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Research Institute', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Dorothy Hatsukami, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We will share data with both internal and external researchers. Those external researchers interested in accessing the data will be required to submit a data analyses proposal with specific aims, hypotheses, and data analyses plan. These proposals will be reviewed by the investigative team. The requested data will then be provided that includes the variable list, raw data and description of the measures and methods of data collection.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}