Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 4:25 AM
Study NCT ID:
NCT02630069
Status:
UNKNOWN
Last Update Posted:
2022-08-01
First Post:
2015-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CDP-choline Treatment in ATS Users
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': 'D003566', 'term': 'Cytidine Diphosphate Choline'}], 'ancestors': [{'id': 'D002794', 'term': 'Choline'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D003565', 'term': 'Cytidine Diphosphate'}, {'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2015-12-06', 'studyFirstSubmitQcDate': '2015-12-10', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening', 'timeFrame': 'baseline through 12 weeks'}, {'measure': 'abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples', 'timeFrame': 'baseline through 12 weeks'}, {'measure': 'treatment program retention', 'timeFrame': 'baseline through 12 weeks'}], 'secondaryOutcomes': [{'measure': 'standardized scores on a neuropsychological test battery', 'timeFrame': 'baseline and 12 weeks'}, {'measure': 'number of participants with adverse events', 'timeFrame': 'baseline through 12 weeks'}, {'measure': 'structural brain changes in magnetic resonance imaging assessed by computational approaches', 'timeFrame': 'baseline and 12 weeks'}, {'measure': 'functional brain changes in magnetic resonance imaging assessed by computational approaches', 'timeFrame': 'baseline and 12 weeks'}, {'measure': 'metabolic brain changes in magnetic resonance imaging assessed by computational approaches', 'timeFrame': 'baseline and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['amphetamine type stimulant', 'adolescents'], 'conditions': ['Substance Use Disorders']}, 'descriptionModule': {'briefSummary': "This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.", 'detailedDescription': "This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline (CDP-choline) in amphetamine-type stimulants-using adolescents. Multi-level assessments will be performed to determine whether CDP-choline administration with supportive psychotherapy, compared to placebo administration with supportive psychotherapy, will 1) repair ATS-induced neural cell damage of the target brain regions, 2) improve cognitive deficits and normalize the relevant target neural circuits, and then 3) reduce ATS-taking behaviors in ATS-using adolescents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 14-40 years\n* Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)\n* Informed consent\n* Seeking treatment\n\nExclusion Criteria:\n\n* Major medical or neurological illnesses\n* Psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions\n* Current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder\n* Occasional ATS use (less than monthly use)\n* IQ of 80 or lower\n* Pregnancy or breastfeeding\n* Clinically significant suicidal or homicidal ideation\n* Substance use disorders (substances other than amphetamine or MA)'}, 'identificationModule': {'nctId': 'NCT02630069', 'briefTitle': 'CDP-choline Treatment in ATS Users', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University Mokdong Hospital'}, 'officialTitle': "Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents", 'orgStudyIdInfo': {'id': 'NIH_ATS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CDP-choline+supportive psychotherapy', 'description': 'CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks', 'interventionNames': ['Drug: CDP-choline', 'Behavioral: Supportive psychotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+supportive psychotherapy', 'description': 'Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks', 'interventionNames': ['Drug: Placebo', 'Behavioral: Supportive psychotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control', 'description': 'No intervention'}], 'interventions': [{'name': 'CDP-choline', 'type': 'DRUG', 'description': 'CDP-choline 500mg once a day for 12 weeks', 'armGroupLabels': ['CDP-choline+supportive psychotherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 500mg once a day for 12 weeks', 'armGroupLabels': ['Placebo+supportive psychotherapy']}, {'name': 'Supportive psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Supportive psychotherapy 1 session/2 weeks for 12 weeks', 'armGroupLabels': ['CDP-choline+supportive psychotherapy', 'Placebo+supportive psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Hui Kim, BSN, RN', 'role': 'CONTACT', 'email': 'ewhactc@nate.com', 'phone': '82-2-2650-2812'}], 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sujung Yoon, MD, PhD', 'role': 'CONTACT', 'email': 'sujungjyoon@ewha.ac.kr', 'phone': '82-2-3277-2478'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University Mokdong Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sujung Yoon', 'investigatorAffiliation': 'Ewha Womans University Mokdong Hospital'}}}}