Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-04 @ 7:36 AM
Study NCT ID:
NCT03861832
Status:
UNKNOWN
Last Update Posted:
2019-03-04
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMART Brain Health in African-Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601005', 'term': 'KB220Z'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two or more groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-01', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Relapse', 'timeFrame': '4 months', 'description': 'Number of times opioids and other types of drugs of abuse are detected in urine'}, {'measure': 'Genetic Testing for the number of risk alleles for Reward Genes through GARS', 'timeFrame': 'Month 1', 'description': 'Number of reward gene variants in opioid use disorder patients compared to controls'}, {'measure': 'Change in assessment of depression, anxiety, PTSD', 'timeFrame': '4 months', 'description': 'Change from Baseline in from the Comprehensive Universal Behavioral Screen for depression, anxiety, PTSD, after 4 months'}, {'measure': 'Change in Reward Deficiency Syndrome Questionnaire (RDSQ)', 'timeFrame': '4 months', 'description': 'Change in risky behaviors'}, {'measure': 'Addiction Severity Index (ASI)', 'timeFrame': '4 months', 'description': 'Change in indices associated with addiction and associated behaviors'}, {'measure': 'Vitamin B6 testing', 'timeFrame': 'Month 4', 'description': 'Presence of B6 in blood to test for compliance with Nutraceutical'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use Disorder', 'Substance Use Disorders', 'Dopamine Dysregulation Syndrome', 'African Americans']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that opioid use in African-Americans will be associated with hypodopaminergic alleles that alter the threshold for activating feelings of reward and pleasure within the dopaminergic system, and that these allelic frequencies will differ significantly from European Americans. Planned is a targeted system to study genetic risks for reward deficiency using risk gene panel to assign a genetic addiction risk score (GARS), comprehensive surveys to determine quality of life and exposure to stressors and trauma. This system will allow prediction of addiction and relapse potential and delivery of personalized treatment.', 'detailedDescription': 'Individuals seeking treatment for Opioid Use Disorder in the Washington DC metro area will be recruited to this Study, which consists of 1) early pre-disposition diagnosis using the Genetic Addiction Risk Score (GARS); 2) Assessment of reward deficiency, co-morbid neuropsychiatric disease, quality of life/happiness, stressors/trauma and other psychometric measurements using validated questionnaires; Urine drug testing during actual treatment that uses comprehensive analysis of reported drugs to determine compliance with prescription medications and non-abstinence to illicit drugs; and 4) adjunctive treatment with neuroadaptogen amino acid therapy (NAAT), a glutaminergic-dopaminergic optimization nutraceutical (generic name: KB220) compared to placebo, aimed to prevent relapse by induction of dopamine homeostasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be able to consent and understand questions being asked during surveys\n* Must be willing to undergo pharmacogenetic testing\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Clinical Diagnosis of Alzheimer's disease/Dementia\n* Clinical Diagnosis of Schizophrenia\n* Clinical Diagnosis of a terminal disorder"}, 'identificationModule': {'nctId': 'NCT03861832', 'acronym': 'SMART', 'briefTitle': 'SMART Brain Health in African-Americans', 'organization': {'class': 'OTHER', 'fullName': 'Howard University'}, 'officialTitle': 'A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder', 'orgStudyIdInfo': {'id': 'R41MD012318-01', 'link': 'https://reporter.nih.gov/quickSearch/R41MD012318-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutraceutical, KB220Z', 'description': 'A nutraceutical pill containing pro-dopamine precursors', 'interventionNames': ['Dietary Supplement: KB220Z']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A placebo that looks the same and is in a similar bottle', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'KB220Z', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['KB220', 'Synaptamine'], 'description': 'Acts to enhance dopamine', 'armGroupLabels': ['Nutraceutical, KB220Z']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20059', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marjorie C. Gondré-Lewis, PhD', 'role': 'CONTACT', 'email': 'mgondre-lewis@Howard.edu', 'phone': '202-806-5274'}, {'name': 'Beverlyn Settles-Reaves, Ph.D.', 'role': 'CONTACT', 'email': 'bsettles-reaves@howard.edu', 'phone': '202-806-7707'}, {'name': 'Tanya Alim, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Howard University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20059', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Medical Home Development Group', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Marjorie C. Gondré-Lewis, Ph.D.', 'role': 'CONTACT', 'email': 'mgondre-lewis@Howard.edu', 'phone': '202-806-5274'}, {'name': 'Beverlyn Settles-Reaves, Ph.D.', 'role': 'CONTACT', 'email': 'bsettles-reaves@howard.edu', 'phone': '202-806-7707'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'within 18 months following completion of the study, and the cleaning of clinical and genomic data', 'ipdSharing': 'YES', 'description': 'The genetic data will be shared when compiled'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Howard University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Home Development Group', 'class': 'UNKNOWN'}, {'name': 'Geneus Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marjorie Gondre-Lewis', 'investigatorAffiliation': 'Howard University'}}}}