Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 9:41 PM
Study NCT ID:
NCT01030406
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2009-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rspivey@acurapharm.com', 'phone': '847-705-7709', 'title': 'Dr. Ron Spivey', 'organization': 'Acura Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '40/0mg', 'description': 'Oxycodone hcl 40mg', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 37, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '80/0mg', 'description': 'Oxycodone hcl 40mg', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 46, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '40/240mg', 'description': 'Oxycodone hcl 40mg/niacin 240mg', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 47, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '80/480ng', 'description': 'Oxycodone hcl 80mg/niacin 480mg', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 49, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '0/0mg', 'description': 'Placebo: Tablets', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 3, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Flushing', 'notes': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA (10.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Drug Liking at .5 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '40/0mg', 'description': '8x Oxycodone/Naicin 5/0mg tablets'}, {'id': 'OG001', 'title': '80/0mg', 'description': '8x Oxycodone/Naicin 10/0mg tablets'}, {'id': 'OG002', 'title': '40/240mg', 'description': '8x Oxycodone/Naicin 5/30mg tablets'}, {'id': 'OG003', 'title': '80/480mg', 'description': '8x Oxycodone/Naicin 10/60mg tablets'}, {'id': 'OG004', 'title': '0/0mg', 'description': 'Placebo: Tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '16.44', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '16.86', 'groupId': 'OG001'}, {'value': '47.7', 'spread': '19.96', 'groupId': 'OG002'}, {'value': '40.9', 'spread': '22.93', 'groupId': 'OG003'}, {'value': '50.3', 'spread': '2.28', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measure collected at 0.5 hours post-dose', 'description': 'Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol completers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '40/0mg Taken First', 'description': 'Ocycodone/Naicin 40/0mg Tablets'}, {'id': 'FG001', 'title': '80/0mg Taken First', 'description': 'Oxycodone/Niacin 80/0mg tablets'}, {'id': 'FG002', 'title': '40/240mg Taken First', 'description': 'Oxycodone?Niacin 40/240mg tablets'}, {'id': 'FG003', 'title': '80/480mg Taken First', 'description': 'Oxycodone/Naicin 80/480mg'}, {'id': 'FG004', 'title': '0/0mg Taken First', 'description': 'Placebo: Tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '40/0mg Taken First', 'description': 'oxycodone.naicin 40/0mg tablets'}, {'id': 'BG001', 'title': '80/0mg Taken First', 'description': 'oxycodone.naicin 80/0mg tablets'}, {'id': 'BG002', 'title': '40/240mg Taken First', 'description': 'oxycodone.naicin 40/240mg tablets'}, {'id': 'BG003', 'title': '80/480mg Taken First', 'description': 'oxycodone.naicin 80/480mg tablets'}, {'id': 'BG004', 'title': '0/0mg Taken First', 'description': 'Placebo Tablets'}, {'id': 'BG005', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '4.83', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '4.83', 'groupId': 'BG001'}, {'value': '23.9', 'spread': '4.83', 'groupId': 'BG002'}, {'value': '23.9', 'spread': '4.83', 'groupId': 'BG003'}, {'value': '23.9', 'spread': '4.83', 'groupId': 'BG004'}, {'value': '23.9', 'spread': '4.83', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 drop out; 1 protocol violation'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Crossover design. Subjects took all drugs in randomized order with a 48 hour washout between doses'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Matching white tablets'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2009-12-10', 'resultsFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-04', 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Liking at .5 Hours', 'timeFrame': 'Measure collected at 0.5 hours post-dose', 'description': 'Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abuse Liability', 'Abuse Prevention', 'Abuse Resistance', 'Abuse Deterrence'], 'conditions': ['Opioid Abuse']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.', 'detailedDescription': 'In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male or female between 18 and 55 years old.\n* Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2.\n* Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision \\[DSM-IV-TR\\]); is able to speak, read, and understand English; and will provide written informed consent.\n* Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).\n\nExclusion Criteria:\n\n* History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.\n* History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.\n* Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.'}, 'identificationModule': {'nctId': 'NCT01030406', 'briefTitle': 'Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acura Pharmaceuticals Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users', 'orgStudyIdInfo': {'id': 'AP-ADF-114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '40/0mg taken first', 'description': '8x oxycodone/niacin 5/0mg tablets', 'interventionNames': ['Drug: 40/0mg taken first']}, {'type': 'ACTIVE_COMPARATOR', 'label': '80/0mg taken first', 'description': '8x oxycodone/niacin 10/0mg tablets', 'interventionNames': ['Drug: 80/0mg taken first']}, {'type': 'EXPERIMENTAL', 'label': '40/240mg taken first', 'description': '8x oxycodone/niacin 5/30mg tablets', 'interventionNames': ['Drug: 40/240mg taken first']}, {'type': 'EXPERIMENTAL', 'label': '80/480mg taken first', 'description': '8x oxycodone/niacin 10/60mg tablets', 'interventionNames': ['Drug: 80/480mg taken first']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0/0mg taken first', 'description': 'Placebo', 'interventionNames': ['Drug: 0/0mg taken first']}], 'interventions': [{'name': '40/0mg taken first', 'type': 'DRUG', 'description': '8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses', 'armGroupLabels': ['40/0mg taken first']}, {'name': '80/0mg taken first', 'type': 'DRUG', 'description': '8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses', 'armGroupLabels': ['80/0mg taken first']}, {'name': '40/240mg taken first', 'type': 'DRUG', 'description': '8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses', 'armGroupLabels': ['40/240mg taken first']}, {'name': '80/480mg taken first', 'type': 'DRUG', 'description': '8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses', 'armGroupLabels': ['80/480mg taken first']}, {'name': '0/0mg taken first', 'type': 'DRUG', 'description': 'Placebo All arms taken with a 48 hour washout between doses', 'armGroupLabels': ['0/0mg taken first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Lifetree Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Lynne Webster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lifetree Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acura Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'King Pharmaceuticals is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}