Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-21 @ 1:35 AM
Study NCT ID:
NCT00640835
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2008-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ed.johnson@reckittbenckiser.com', 'phone': '804-379-1090', 'title': 'Rolley E. Johnson, PharmD, Vice President, Clinical, Scientific and Regulatory Affairs', 'phoneExt': '7089', 'organization': 'Reckitt Benckiser Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Buprenorphine/Naloxone Film Strip Administered Sublingually', 'otherNumAtRisk': 194, 'otherNumAffected': 11, 'seriousNumAtRisk': 194, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Buprenorphine/Naloxone Film Strip Administered Buccally', 'otherNumAtRisk': 188, 'otherNumAffected': 16, 'seriousNumAtRisk': 188, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Oral mucosal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Squamous cell carcinoma of the cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine/Naloxone Film Strip Administered Sublingually'}, {'id': 'OG001', 'title': 'Buprenorphine/Naloxone Film Strip Administered Buccally'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:\n\nGrade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.', 'anticipatedPostingDate': '2009-12'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine/Naloxone Film Strip Administered Sublingually'}, {'id': 'OG001', 'title': 'Buprenorphine/Naloxone Film Strip Administered Buccally'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buprenorphine/Naloxone Film Strip Administered Sublingually'}, {'id': 'FG001', 'title': 'Buprenorphine/Naloxone Film Strip Administered Buccally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Patient enrollment commenced 02/28/08 and was completed 04/15/08. All sites were medical clinics.', 'preAssignmentDetails': 'Subjects were required to be on a stabilized dose of buprenorphine and naloxone for at least 30 days prior to study drug administration, either during the screening period, or as part of routine medical treatment during the previous 30 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Buprenorphine/Naloxone Film Strip Administered Sublingually'}, {'id': 'BG001', 'title': 'Buprenorphine/Naloxone Film Strip Administered Buccally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '10.19', 'groupId': 'BG000'}, {'value': '36.7', 'spread': '10.09', 'groupId': 'BG001'}, {'value': '36.4', 'spread': '10.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age Categorical', 'classes': [{'title': '<21', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '21 - 35', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}, {'title': '36 - 50', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': '>50', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The age categories used for this study were slightly different than the standard values and are reflected as reported in the study.', 'unitOfMeasure': 'Participants'}, {'title': 'Severity Grading of Oral Mucosa', 'classes': [{'title': 'Grade 0', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Safety and tolerability were evaluated at baseline by oral cavity examination. Oral mucosa was graded as follows:\n\nGrade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'dispFirstSubmitDate': '2010-09-30', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2008-03-14', 'dispFirstSubmitQcDate': '2010-09-30', 'resultsFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2008-03-14', 'dispFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-30', 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.', 'timeFrame': '12 weeks', 'description': 'Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:\n\nGrade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs'}, {'measure': 'Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity', 'timeFrame': '12 weeks', 'description': 'Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid dependence'], 'conditions': ['Opioid-Related Disorders']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.', 'detailedDescription': 'Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product:\n\n* mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.\n* improvement in subject convenience and compliance by ensuring rapid disintegration.\n* protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.\n* provision of a unit dose product format for hospital and institutional use.\n* decreased product damage during shipping as compared to Suboxone tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must:\n\n* Be 18-to-65 years of age, inclusive.\n* Have a diagnosis of opioid dependence by medical history according to DSM-IV-TR criteria.\n* Be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of Suboxone for at least 30 days.\n* If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control which may include:\n\nExclusion Criteria:\n\nSubjects must not:\n\n* Have participated in an experimental drug or device study within the last 30 days.\n* If female, be breast feeding or lactating.\n* Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.\n* Have a clinically significant abnormal finding (in the opinion of the Investigator) on oral cavity exam (e.g., active mouth ulcers).\n* Have any piercing of the tongue or mouth within 30 days prior to the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT00640835', 'briefTitle': 'Safety and Tolerability of Buprenorphine/Naloxone Film Strips', 'organization': {'class': 'INDUSTRY', 'fullName': 'Indivior Inc.'}, 'officialTitle': 'A Phase 2 Multi-Center Open-label Study to Assess the Safety and Tolerability of a Buprenorphine/Naloxone Film Strip Administered by the Sublingual and Buccal Routes', 'orgStudyIdInfo': {'id': 'RB-US-07-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sublingual administration', 'description': 'Buprenorphine/naloxone film strip administered sublingually', 'interventionNames': ['Drug: Buprenorphine/naloxone Film Strip']}, {'type': 'EXPERIMENTAL', 'label': 'Buccal administration', 'description': 'Buprenorphine/naloxone film strip administered buccally', 'interventionNames': ['Drug: Buprenorphine/naloxone Film Strip']}], 'interventions': [{'name': 'Buprenorphine/naloxone Film Strip', 'type': 'DRUG', 'description': 'Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route', 'armGroupLabels': ['Sublingual administration']}, {'name': 'Buprenorphine/naloxone Film Strip', 'type': 'DRUG', 'description': 'Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route', 'armGroupLabels': ['Buccal administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35565', 'city': 'Haleyville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Winston Technology Research LLC', 'geoPoint': {'lat': 34.22649, 'lon': -87.62141}}, {'zip': '32250', 'city': 'Jacksonville Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Beeches Family Medicine', 'geoPoint': {'lat': 30.29469, 'lon': -81.39314}}], 'overallOfficials': [{'name': 'Donald R. Jasinski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indivior Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}