Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 10:56 AM
Study NCT ID:
NCT01813656
Status:
TERMINATED
Last Update Posted:
2015-02-04
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Study of Aripiprazole in the Treatment of Methamphetamine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Aripiprazole arm had obvious adverse reactions,especially akathisia.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2013-03-15', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'abstinent time of Methamphetamine addict', 'timeFrame': 'up to 3 months', 'description': 'methamphetamine-positive urine test results,self-reports of substance use'}], 'secondaryOutcomes': [{'measure': 'number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'up to 3 months', 'description': 'use Abnormal Involuntary Movement Scale ,Simpson-Angus Scale and Barnes akathisia Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methamphetamine-Associated Psychosis', 'Aripiprazole'], 'conditions': ['Methamphetamine Dependence']}, 'descriptionModule': {'briefSummary': 'Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have different pharmacological effects of neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among mehtamphetamine addicts.', 'detailedDescription': 'Methods:A Multiple-Center, Randomized, Double-Blind.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine dependence.\n2. Must sign a Information consent form.\n3. Required to provide detailed address and phone number\n\nExclusion Criteria:\n\n1. Serious organic disease.\n2. Suicide ideation or hurt others.\n3. Taking antipsychotic within two weeks before.\n4. drug allergy to Risperidone or Aripiprazole.\n5. pregnancy and breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT01813656', 'briefTitle': 'An Study of Aripiprazole in the Treatment of Methamphetamine Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'A Multiple-Center, Randomized, Double-Blind Study of Aripiprazole for Treatment of Methamphetamine Dependence', 'orgStudyIdInfo': {'id': '100000-068942'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aripiprazole', 'description': 'Aripiprazole arm,5mg/pill,10mg/day.last12weeks.', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'placebo arm,5mg/pill,10mg/day,last12weeks', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Aopai H20041507'], 'description': 'Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks', 'armGroupLabels': ['Aripiprazole']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo group,5mg/pill,10mg/day non-forced titration method,last 12 weeks', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Wei Hao, MD., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Hao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Second Xiangya Hospital of Cental South University', 'investigatorFullName': 'Wei Hao', 'investigatorAffiliation': 'Central South University'}}}}