Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00332605
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2006-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'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'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jongrant@uchicago.edu', 'phone': '773-834-1325', 'title': 'Jon E. Grant', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Naltrexone', 'description': 'Naltrexone tablets - 50mg pills taken by mouth daily', 'otherNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'N-Acetyl Cysteine', 'description': '600mg tablets taken by mouth daily', 'otherNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Inactive pill taken by mouth daily', 'otherNumAtRisk': 17, 'otherNumAffected': 7, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Penn Craving Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Naltrexone tablets'}, {'id': 'OG001', 'title': 'N-Acetyl Cysteine', 'description': '600mg tablets, daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'beginning and at each visit until the end of their participation in the study', 'description': 'used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported scores are Mean and standard deviation for Subjects last visit (including last-observation carried forward).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naltrexone', 'description': 'Naltrexone tablets - 50mg pills taken by mouth daily'}, {'id': 'FG001', 'title': 'N-Acetyl Cysteine', 'description': '600mg tablets taken by mouth daily'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Inactive pill taken by mouth daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'July 2006 - September 2009'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Naltrexone', 'description': 'Naltrexone tablets - 50mg pills taken by mouth daily'}, {'id': 'BG001', 'title': 'N-Acetyl Cysteine', 'description': '600mg tablets taken by mouth daily'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Inactive pill taken by mouth daily'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '36.1', 'spread': '6.6', 'groupId': 'BG002'}, {'value': '36.9', 'spread': '7.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2006-05-30', 'resultsFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2006-05-30', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-06-18', 'studyFirstPostDateStruct': {'date': '2006-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Penn Craving Scale', 'timeFrame': 'beginning and at each visit until the end of their participation in the study', 'description': 'used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methamphetamine Dependence'], 'conditions': ['Methamphetamine Dependence']}, 'descriptionModule': {'briefSummary': 'The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in combination with naltrexone in methamphetamine dependence.', 'detailedDescription': 'Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine dependence compared to placebo. The proposed study will provide needed data on the treatment of a public health crisis that currently lacks a clearly effective treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. men and women age 18-65\n2. current DSM-IV methamphetamine dependence.\n\nExclusion Criteria:\n\n1. unstable medical illness\n2. history of seizures\n3. myocardial infarction within 6 months\n4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential\n5. any thoughts of suicide\n6. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder\n7. previous treatment with N-Acetyl Cysteine or naltrexone\n8. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline\n9. abnormal liver function tests at screening\n10. diagnosis of asthma\n11. current use of opiates.'}, 'identificationModule': {'nctId': 'NCT00332605', 'briefTitle': 'N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence', 'orgStudyIdInfo': {'id': '0601M80486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naltrexone plus N-Acetyl Cysteine', 'description': 'Naltrexone tablets\n\nN-Acetyl Cysteine: 600mg tablets, daily', 'interventionNames': ['Drug: Naltrexone plus N-Acetyl Cysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inactive placebo ("sugar pill")', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naltrexone plus N-Acetyl Cysteine', 'type': 'DRUG', 'otherNames': ['Naltrexone:', 'Revia'], 'description': 'daily', 'armGroupLabels': ['Naltrexone plus N-Acetyl Cysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jon E Grant, MD, JD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}