Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-11 @ 4:17 PM
Study NCT ID:
NCT02951858
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2016-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Substance Use Screening Among Drug User
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2016-10-23', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk Behaviors measured by ASSIST questionnaire', 'timeFrame': '1 month', 'description': 'Risk Behaviors will be measured by ASSIST questionnaire.'}, {'measure': 'Knowledge related to Substance Use measured by Knowledge related to Addiction questionnaire', 'timeFrame': '1 month', 'description': 'Knowledge related to substance use will be measured by Knowledge related to Addiction questionnaire.'}, {'measure': 'Motivation measured by Pre-treatment Readiness Scale', 'timeFrame': '1 month', 'description': 'Motivation will be measured by Pre-treatment Readiness Scale (PRS).'}], 'secondaryOutcomes': [{'measure': 'Depression measured by Self-Rating Depression Scale', 'timeFrame': '1 month', 'description': 'the change of depression will be measured by Self-Rating Depression Scale (SDS).'}, {'measure': 'Anxiety measured by Self-Rating Anxiety Scale', 'timeFrame': '1 month', 'description': 'the change of anxiety will be measured by Self-Rating Anxiety Scale (SAS).'}, {'measure': 'Self-esteem measured by Self-esteem questionnaire', 'timeFrame': '1 month', 'description': 'the change of self-esteem will be measured by Self-esteem questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol,Smoking,and Substance Use Involvement Screening Test', 'Brief Intervention', 'Substance Use', 'Primary Medical and Health Care Institution'], 'conditions': ['Substance Use']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to improve the ability of primary medical staffs in screening and intervention for alcohol, benzodiazepines, and other illicit drug use.', 'detailedDescription': 'In order to reduce the social and personal harm caused by drugs, it is urgent to strengthen the ability of the primary health institutions in screening and intervention the addictive substances use. Firstly, the investigators will invite 10 primary medical staffs and 10 experts in addition to revise the manual of Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) and Brief Intervention (BI). Then, the investigators will recruit 100 medical staffs to participate the training of ASSIST and BI. Secondly, the researcher will investigate the effects of BI technology in reducing the use of addictive substances, improve the addiction related knowledge of patients through randomized controlled study. Finally, the investigators will collect the research information, revise the manual, and promote the training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18-60 years;\n2. the patient to the community medical institutions;\n3. ASSIST score is in 12-27, in a moderate risk;\n4. voluntary to participate;\n5. to agree to complete baseline interviews and follow-up studies.\n\nExclusion Criteria:\n\n1. unable to complete the questionnaire;\n2. serious physical illness, action inconvenience.'}, 'identificationModule': {'nctId': 'NCT02951858', 'briefTitle': 'Substance Use Screening Among Drug User', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Screening and Brief Interventions for Substance Use in Primary Medical Institution', 'orgStudyIdInfo': {'id': 'JDu-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The medical staffs who received the training will use the manual of brief intervention to deliver it and other materials about the harm of substance use.', 'interventionNames': ['Behavioral: Intervention Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The participants only receive the materials about the harm of substance use.', 'interventionNames': ['Behavioral: Control Group']}], 'interventions': [{'name': 'Intervention Group', 'type': 'BEHAVIORAL', 'description': 'The medical staffs who received the training will use the manual of brief intervention to deliver BI and other materials about the harm of substance use.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Control Group', 'type': 'BEHAVIORAL', 'description': 'The participants only receive the materials about the harm of substance use.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiang Du, M.D', 'role': 'CONTACT', 'email': 'dujiangdou@163.com', 'phone': '18017311220'}], 'overallOfficials': [{'name': 'Jiang Du, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cheif Physician', 'investigatorFullName': 'DU, Jiang', 'investigatorAffiliation': 'Shanghai Mental Health Center'}}}}