Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT02285556
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2014-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019969', 'term': 'Amphetamine-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2014-08-19', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevalence of ATS abuse or dependence characteristics and pathogenesis', 'timeFrame': 'Baseline', 'description': 'Plasma and DNA samples were collected to carry out the biochemical genetics and immunology research of ATS abuse or dependence , and to explore the prevalence of ATS abuse or dependence characteristics and pathogenesis.'}, {'measure': 'the physiological psychology and cognitive impairment characteristic of ATS addicts,trends and ATS conducted cases.', 'timeFrame': 'Baseline', 'description': 'Use repeatable battery for the assessment of neuropsychological status(RBANS),Cog-state cognitive function assessment test,event-related potentials(ERPs),functional magnetic resonance imaging(fMRI) in biology ( molecular genetics, blood biochemistry, electrophysiology , imaging ) , psychology, mental health and other aspects of the system to assess the physiological psychology and cognitive impairment characteristic of ATS addicts , trends and ATS conducted cases.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug carving changes during rehabilitation', 'community', 'DNA'], 'conditions': ['Amphetamine Addiction']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage.', 'detailedDescription': 'The study will increase the sample size based on the preliminary work,also, establish drug dependence induced craving associated environmental experiments , by using the multi-lead biofeedback instrument , CogState tester, event-related potentials Recorder and 3.0T high-field magnetic resonance imaging system to record the physiology , electrophysiology and brain changes during craving, taking a subjective self-assessment , clinical observations and physiological responses combined system to evaluate the ATS addiction degree.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No previous history of any mental disorder meet the DSM-IV diagnosis\n* aged 18-49 years old , men and women\n* junior high school or higher education\n* use of amphetamine-type substances time for more than one year\n* cumulative use of amphetamines, substances dose of 50 grams or more.\n\nExclusion Criteria:\n\n* Current or past had suffered neurological diseases\n* exclusion of antisocial personality disorder and borderline personality disorder\n* addicts in addition to other substances in tobacco , coffee, social drinking outside\n* AIDS virus (HIV) detection positive patients .'}, 'identificationModule': {'nctId': 'NCT02285556', 'briefTitle': 'The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus', 'orgStudyIdInfo': {'id': 'MZhao-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'general information', 'description': "use cross-sectional study to collect 1000 ATS abuse or dependence patients' general information and 5 ml blood,get their blood plasma and DNA sample in order to explore the possible addict mechanism."}, {'type': 'NO_INTERVENTION', 'label': 'ATS diagnosis and evaluation for abusers', 'description': 'Use cohort study design to establish ATS abuse induced craving experiment.Do the initial and follow-up assessment from start smoking to stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . Thus compare with normal group to explore the possible psychological abuse mechanism.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'psychological training intervention', 'description': 'The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.', 'interventionNames': ['Behavioral: psychological rehabilitation training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'brain stimulation intervention', 'description': 'Use randomized, prospective pseudo stimulus controlled clinical trial design, evaluation of repetitive transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.', 'interventionNames': ['Radiation: rTMS 10HZ high frequency stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'ATS diagnosis and evaluation for normal people', 'description': 'Do the same initial and follow-up assessment as ATS abusers who stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community .'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'physical and neurological rehabilitation', 'description': 'The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .', 'interventionNames': ['Behavioral: physical and neurological rehabilitation training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'fake brain stimulation intervention', 'description': 'fake transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.', 'interventionNames': ['Radiation: fake rTMS 10HZ high frequency stimulation']}], 'interventions': [{'name': 'psychological rehabilitation training', 'type': 'BEHAVIORAL', 'description': 'The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.', 'armGroupLabels': ['psychological training intervention']}, {'name': 'physical and neurological rehabilitation training', 'type': 'BEHAVIORAL', 'description': 'The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .', 'armGroupLabels': ['physical and neurological rehabilitation']}, {'name': 'rTMS 10HZ high frequency stimulation', 'type': 'RADIATION', 'description': 'Stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).', 'armGroupLabels': ['brain stimulation intervention']}, {'name': 'fake rTMS 10HZ high frequency stimulation', 'type': 'RADIATION', 'description': 'Fake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).', 'armGroupLabels': ['fake brain stimulation intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Min Zhao, ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Min ZHAO', 'investigatorAffiliation': 'Shanghai Mental Health Center'}}}}