Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-08 @ 11:48 PM
Study NCT ID:
NCT03338933
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neurobiology of Alcohol and Nicotine Co-Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hoffmaw@ohsu.edu', 'phone': '503-220-8262', 'title': 'Dr. William Hoffman', 'phoneExt': '56214', 'organization': 'VA Portland Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Activation During Functional Magnetic Resonance Imaging (fMRI) in Response to a Stress Modulated Cue Induced Craving Task (DSNBACK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG001', 'title': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG002', 'title': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG003', 'title': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}], 'classes': [{'title': 'Anterior Cingulate Cortex', 'categories': [{'measurements': [{'value': '-26.1562', 'spread': '163.7528', 'groupId': 'OG000'}, {'value': '-45.2123', 'spread': '142.7251', 'groupId': 'OG001'}, {'value': '18.4989', 'spread': '119.7023', 'groupId': 'OG002'}, {'value': '-8.8848', 'spread': '93.3926', 'groupId': 'OG003'}]}]}, {'title': 'Amygdala', 'categories': [{'measurements': [{'value': '-37.6450', 'spread': '101.1780', 'groupId': 'OG000'}, {'value': '-72.3998', 'spread': '160.9536', 'groupId': 'OG001'}, {'value': '-36.6553', 'spread': '143.9042', 'groupId': 'OG002'}, {'value': '-17.9994', 'spread': '119.2175', 'groupId': 'OG003'}]}]}, {'title': 'Hippocampus', 'categories': [{'measurements': [{'value': '-31.8272', 'spread': '106.1173', 'groupId': 'OG000'}, {'value': '-45.4345', 'spread': '124.8141', 'groupId': 'OG001'}, {'value': '-69.7126', 'spread': '115.1060', 'groupId': 'OG002'}, {'value': '-37.1105', 'spread': '135.3652', 'groupId': 'OG003'}]}]}, {'title': 'Insula', 'categories': [{'measurements': [{'value': '-0.7322', 'spread': '152.9914', 'groupId': 'OG000'}, {'value': '-73.3807', 'spread': '160.7811', 'groupId': 'OG001'}, {'value': '61.6090', 'spread': '138.2172', 'groupId': 'OG002'}, {'value': '-42.4399', 'spread': '146.2034', 'groupId': 'OG003'}]}]}, {'title': 'Medial Orbital Frontal Cortex', 'categories': [{'measurements': [{'value': '-35.9220', 'spread': '52.9373', 'groupId': 'OG000'}, {'value': '-22.4666', 'spread': '55.9283', 'groupId': 'OG001'}, {'value': '37.5445', 'spread': '95.7412', 'groupId': 'OG002'}, {'value': '-12.6343', 'spread': '42.7803', 'groupId': 'OG003'}]}]}, {'title': 'Nucleus Accumbens', 'categories': [{'measurements': [{'value': '-56.2479', 'spread': '193.2017', 'groupId': 'OG000'}, {'value': '-121.6585', 'spread': '258.8531', 'groupId': 'OG001'}, {'value': '-133.8492', 'spread': '123.4497', 'groupId': 'OG002'}, {'value': '-40.6751', 'spread': '112.4257', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The DSN-back is a cognitive task used to assess working memory and attention. Participants view a sequence of letters presented on a screen, flanked by either drug-related or neutral images, and are instructed to identify matches occurring N steps earlier. Neural activation during high working memory demand condition (2-back) relative to the low working memory condition (0-back) was investigated. Inconsistent activation patterns across regions may indicate impaired neural processing in regions critical for cognitive control, emotion regulation, and reward processing, commonly reported in substance use disorders. Values closer to 0 (no change) in regions responsible for emotion regulation and cognitive control (e.g., Amygdala, ACC) may indicate reduced task-specific engagement where drug-related processes may be dominating neural activity.', 'unitOfMeasure': 'Percent signal change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were removed from analysis due to too much motion, performing the task incorrectly, or did not perform the task during the MRI session.'}, {'type': 'PRIMARY', 'title': 'Brain Activation During Resting State MRI.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG001', 'title': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG002', 'title': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG003', 'title': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}], 'classes': [{'title': 'Anterior Cingulate Cortex (ACC)', 'categories': [{'measurements': [{'value': '0.1817', 'spread': '0.1460', 'groupId': 'OG000'}, {'value': '0.1858', 'spread': '0.1576', 'groupId': 'OG001'}, {'value': '0.1729', 'spread': '0.0973', 'groupId': 'OG002'}, {'value': '0.1308', 'spread': '0.0959', 'groupId': 'OG003'}]}]}, {'title': 'Amygdala', 'categories': [{'measurements': [{'value': '0.1293', 'spread': '0.1124', 'groupId': 'OG000'}, {'value': '0.1216', 'spread': '0.1148', 'groupId': 'OG001'}, {'value': '0.0232', 'spread': '0.0903', 'groupId': 'OG002'}, {'value': '0.0930', 'spread': '0.0682', 'groupId': 'OG003'}]}]}, {'title': 'Hippocampus', 'categories': [{'measurements': [{'value': '0.0391', 'spread': '0.0998', 'groupId': 'OG000'}, {'value': '0.0746', 'spread': '0.1068', 'groupId': 'OG001'}, {'value': '0.0255', 'spread': '0.0791', 'groupId': 'OG002'}, {'value': '0.0348', 'spread': '0.0609', 'groupId': 'OG003'}]}]}, {'title': 'Insula', 'categories': [{'measurements': [{'value': '0.2297', 'spread': '0.1390', 'groupId': 'OG000'}, {'value': '0.3139', 'spread': '0.1958', 'groupId': 'OG001'}, {'value': '0.2134', 'spread': '0.1306', 'groupId': 'OG002'}, {'value': '0.2386', 'spread': '0.1829', 'groupId': 'OG003'}]}]}, {'title': 'Medial Orbital Frontal Cortex (OFC)', 'categories': [{'measurements': [{'value': '0.0469', 'spread': '0.0398', 'groupId': 'OG000'}, {'value': '0.0574', 'spread': '0.0420', 'groupId': 'OG001'}, {'value': '0.0726', 'spread': '0.0456', 'groupId': 'OG002'}, {'value': '0.0327', 'spread': '0.0397', 'groupId': 'OG003'}]}]}, {'title': 'Lateral OFC', 'categories': [{'measurements': [{'value': '0.0769', 'spread': '0.0739', 'groupId': 'OG000'}, {'value': '0.1212', 'spread': '0.0826', 'groupId': 'OG001'}, {'value': '0.0969', 'spread': '0.0587', 'groupId': 'OG002'}, {'value': '0.0770', 'spread': '0.0655', 'groupId': 'OG003'}]}]}, {'title': 'Bilateral Middle Frontal Gyrus', 'categories': [{'measurements': [{'value': '-0.0501', 'spread': '0.0996', 'groupId': 'OG000'}, {'value': '-0.0128', 'spread': '0.1573', 'groupId': 'OG001'}, {'value': '0.0393', 'spread': '0.0580', 'groupId': 'OG002'}, {'value': '-0.0184', 'spread': '0.0974', 'groupId': 'OG003'}]}]}, {'title': 'Rostral ACC', 'categories': [{'measurements': [{'value': '0.1610', 'spread': '0.1664', 'groupId': 'OG000'}, {'value': '0.2674', 'spread': '0.1721', 'groupId': 'OG001'}, {'value': '0.2327', 'spread': '0.1361', 'groupId': 'OG002'}, {'value': '0.1293', 'spread': '0.1124', 'groupId': 'OG003'}]}]}, {'title': 'Caudal ACC', 'categories': [{'measurements': [{'value': '0.1884', 'spread': '0.1459', 'groupId': 'OG000'}, {'value': '0.1574', 'spread': '0.1361', 'groupId': 'OG001'}, {'value': '0.1598', 'spread': '0.1027', 'groupId': 'OG002'}, {'value': '0.1323', 'spread': '0.1121', 'groupId': 'OG003'}]}]}, {'title': 'Bilateral Anterior Insula', 'categories': [{'measurements': [{'value': '0.2561', 'spread': '0.1766', 'groupId': 'OG000'}, {'value': '0.3575', 'spread': '0.2270', 'groupId': 'OG001'}, {'value': '0.2477', 'spread': '0.1456', 'groupId': 'OG002'}, {'value': '0.2817', 'spread': '0.1945', 'groupId': 'OG003'}]}]}, {'title': 'Bilateral Dorsal Anterior Insula', 'categories': [{'measurements': [{'value': '0.3803', 'spread': '0.2124', 'groupId': 'OG000'}, {'value': '0.4823', 'spread': '0.2517', 'groupId': 'OG001'}, {'value': '0.3249', 'spread': '0.1984', 'groupId': 'OG002'}, {'value': '0.3775', 'spread': '0.2760', 'groupId': 'OG003'}]}]}, {'title': 'Bilateral Ventral Anterior Insula', 'categories': [{'measurements': [{'value': '0.1541', 'spread': '0.1739', 'groupId': 'OG000'}, {'value': '0.2554', 'spread': '0.2228', 'groupId': 'OG001'}, {'value': '0.1852', 'spread': '0.1200', 'groupId': 'OG002'}, {'value': '0.2039', 'spread': '0.1538', 'groupId': 'OG003'}]}]}, {'title': 'midbrain', 'categories': [{'measurements': [{'value': '0.0037', 'spread': '0.1067', 'groupId': 'OG000'}, {'value': '0.0390', 'spread': '0.0987', 'groupId': 'OG001'}, {'value': '0.0380', 'spread': '0.0903', 'groupId': 'OG002'}, {'value': '0.0306', 'spread': '0.1308', 'groupId': 'OG003'}]}]}, {'title': 'Right Dorsal Lateral Prefrontal Cortex', 'categories': [{'measurements': [{'value': '0.0251', 'spread': '0.1323', 'groupId': 'OG000'}, {'value': '0.0504', 'spread': '0.1995', 'groupId': 'OG001'}, {'value': '0.0074', 'spread': '0.0267', 'groupId': 'OG002'}, {'value': '0.1052', 'spread': '0.1409', 'groupId': 'OG003'}]}]}, {'title': 'Sub Callosal Cortex', 'categories': [{'measurements': [{'value': '0.0224', 'spread': '0.0582', 'groupId': 'OG000'}, {'value': '0.0673', 'spread': '0.0489', 'groupId': 'OG001'}, {'value': '0.1034', 'spread': '0.0738', 'groupId': 'OG002'}, {'value': '0.0495', 'spread': '0.0533', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'This outcome measures resting-state functional connectivity (rsFC) of the striatum using seed-based analysis of resting-state fMRI data. FC values, expressed as Fisher z-transformed correlation coefficients, quantify the strength of synchronization between the striatum seed region and other brain areas. Positive values indicate synchronized activity, while negative values reflect anticorrelation. Altered rsFC of the striatum, a hub for reward processing, habit formation, and executive control, is linked to alcohol and nicotine use disorders and may indicate impaired regulation of cravings and heightened sensitivity to substance-related cues. Investigating rsFC patterns may identify biomarkers of addiction severity, predict treatment outcomes, and inform potential therapeutic targets.', 'unitOfMeasure': 'correlation coefficient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were removed from analysis due to too much motion, performing the task incorrectly, or did not perform the task during the MRI session.'}, {'type': 'PRIMARY', 'title': 'Brain Cortical Thickness Assessed During MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG001', 'title': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG002', 'title': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG003', 'title': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}], 'classes': [{'title': 'Left caudal anterior cingulate', 'categories': [{'measurements': [{'value': '2.6111', 'spread': '0.2171', 'groupId': 'OG000'}, {'value': '2.5421', 'spread': '0.1780', 'groupId': 'OG001'}, {'value': '2.5472', 'spread': '0.2005', 'groupId': 'OG002'}, {'value': '2.6560', 'spread': '0.5697', 'groupId': 'OG003'}]}]}, {'title': 'Left inferior parietal cortex', 'categories': [{'measurements': [{'value': '2.4885', 'spread': '0.0862', 'groupId': 'OG000'}, {'value': '2.4414', 'spread': '0.0675', 'groupId': 'OG001'}, {'value': '2.3881', 'spread': '0.0586', 'groupId': 'OG002'}, {'value': '2.4132', 'spread': '0.5030', 'groupId': 'OG003'}]}]}, {'title': 'Left rostral anterior cingulate', 'categories': [{'measurements': [{'value': '2.7960', 'spread': '0.1675', 'groupId': 'OG000'}, {'value': '2.7058', 'spread': '0.1977', 'groupId': 'OG001'}, {'value': '2.7173', 'spread': '0.1454', 'groupId': 'OG002'}, {'value': '2.7150', 'spread': '0.5749', 'groupId': 'OG003'}]}]}, {'title': 'Left rostral middle frontal cortex', 'categories': [{'measurements': [{'value': '2.4701', 'spread': '0.0898', 'groupId': 'OG000'}, {'value': '2.4315', 'spread': '0.0752', 'groupId': 'OG001'}, {'value': '2.3740', 'spread': '0.0794', 'groupId': 'OG002'}, {'value': '2.4406', 'spread': '0.5069', 'groupId': 'OG003'}]}]}, {'title': 'Left supramarginal cortex', 'categories': [{'measurements': [{'value': '2.6022', 'spread': '0.1315', 'groupId': 'OG000'}, {'value': '2.5550', 'spread': '0.0838', 'groupId': 'OG001'}, {'value': '2.4669', 'spread': '0.0656', 'groupId': 'OG002'}, {'value': '2.5375', 'spread': '0.5283', 'groupId': 'OG003'}]}]}, {'title': 'Right caudal anterior cingulate', 'categories': [{'measurements': [{'value': '2.4662', 'spread': '0.1935', 'groupId': 'OG000'}, {'value': '2.4350', 'spread': '0.1495', 'groupId': 'OG001'}, {'value': '2.3582', 'spread': '0.1392', 'groupId': 'OG002'}, {'value': '2.4452', 'spread': '0.5130', 'groupId': 'OG003'}]}]}, {'title': 'Right inferior parietal cortex', 'categories': [{'measurements': [{'value': '2.5510', 'spread': '0.0803', 'groupId': 'OG000'}, {'value': '2.5175', 'spread': '0.0953', 'groupId': 'OG001'}, {'value': '2.4377', 'spread': '0.0324', 'groupId': 'OG002'}, {'value': '2.4774', 'spread': '0.5158', 'groupId': 'OG003'}]}]}, {'title': 'Right rostral anterior cingulate', 'categories': [{'measurements': [{'value': '2.8013', 'spread': '0.1454', 'groupId': 'OG000'}, {'value': '2.6618', 'spread': '0.2390', 'groupId': 'OG001'}, {'value': '2.6828', 'spread': '0.1466', 'groupId': 'OG002'}, {'value': '2.7507', 'spread': '0.5852', 'groupId': 'OG003'}]}]}, {'title': 'Right rostral middle frontal cortex', 'categories': [{'measurements': [{'value': '2.3994', 'spread': '0.1024', 'groupId': 'OG000'}, {'value': '2.3699', 'spread': '0.0777', 'groupId': 'OG001'}, {'value': '2.3103', 'spread': '0.0640', 'groupId': 'OG002'}, {'value': '2.3443', 'spread': '0.4864', 'groupId': 'OG003'}]}]}, {'title': 'Right supramarginal cortex', 'categories': [{'measurements': [{'value': '2.6165', 'spread': '0.1221', 'groupId': 'OG000'}, {'value': '2.5694', 'spread': '0.0666', 'groupId': 'OG001'}, {'value': '2.4713', 'spread': '0.0701', 'groupId': 'OG002'}, {'value': '2.5312', 'spread': '0.5261', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'This outcome measures cortical thickness (millimeters) across brain regions using structural MRI. Cortical thickness reflects the integrity of gray matter and is influenced by factors such as neurodegeneration, plasticity, and development. Reductions in cortical thickness, particularly in prefrontal and limbic regions, are associated with impaired cognitive control, emotion regulation, and decision-making in substance use disorders.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were removed from analysis due to too much motion, performing the task incorrectly, or did not perform the task during the MRI session.'}, {'type': 'PRIMARY', 'title': 'Brain White Matter Integrity as Assessed by Fractional Anisotropy During MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG001', 'title': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG002', 'title': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'OG003', 'title': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}], 'classes': [{'title': 'Forceps Major', 'categories': [{'measurements': [{'value': '0.4167', 'spread': '0.1984', 'groupId': 'OG000'}, {'value': '0.3996', 'spread': '0.1497', 'groupId': 'OG001'}, {'value': '0.4030', 'spread': '0.1900', 'groupId': 'OG002'}, {'value': '0.4044', 'spread': '0.1930', 'groupId': 'OG003'}]}]}, {'title': 'Forceps Minor', 'categories': [{'measurements': [{'value': '0.3794', 'spread': '0.1809', 'groupId': 'OG000'}, {'value': '0.3657', 'spread': '0.1374', 'groupId': 'OG001'}, {'value': '0.3574', 'spread': '0.1685', 'groupId': 'OG002'}, {'value': '0.3589', 'spread': '0.1718', 'groupId': 'OG003'}]}]}, {'title': 'Left Anterior Thalamic Radiation', 'categories': [{'measurements': [{'value': '0.3474', 'spread': '0.1653', 'groupId': 'OG000'}, {'value': '0.3362', 'spread': '0.1257', 'groupId': 'OG001'}, {'value': '0.3356', 'spread': '0.1582', 'groupId': 'OG002'}, {'value': '0.3334', 'spread': '0.1592', 'groupId': 'OG003'}]}]}, {'title': 'Right Anterior Thalamic Radiation', 'categories': [{'measurements': [{'value': '0.3450', 'spread': '0.1642', 'groupId': 'OG000'}, {'value': '0.3337', 'spread': '0.1247', 'groupId': 'OG001'}, {'value': '0.3331', 'spread': '0.1570', 'groupId': 'OG002'}, {'value': '0.3306', 'spread': '0.1578', 'groupId': 'OG003'}]}]}, {'title': 'Left Inferior fronto-occipital fasciculus', 'categories': [{'measurements': [{'value': '0.3536', 'spread': '0.1684', 'groupId': 'OG000'}, {'value': '0.3388', 'spread': '0.1268', 'groupId': 'OG001'}, {'value': '0.3383', 'spread': '0.1595', 'groupId': 'OG002'}, {'value': '0.3374', 'spread': '0.1614', 'groupId': 'OG003'}]}]}, {'title': 'Right Inferior fronto-occipital fasciculus', 'categories': [{'measurements': [{'value': '0.3574', 'spread': '0.1702', 'groupId': 'OG000'}, {'value': '0.3436', 'spread': '0.1287', 'groupId': 'OG001'}, {'value': '0.3422', 'spread': '0.1614', 'groupId': 'OG002'}, {'value': '0.3417', 'spread': '0.1632', 'groupId': 'OG003'}]}]}, {'title': 'Left Temporal Superior longitudinal fasciculus', 'categories': [{'measurements': [{'value': '0.3535', 'spread': '0.1683', 'groupId': 'OG000'}, {'value': '0.3389', 'spread': '0.1269', 'groupId': 'OG001'}, {'value': '0.3392', 'spread': '0.1600', 'groupId': 'OG002'}, {'value': '0.3387', 'spread': '0.1620', 'groupId': 'OG003'}]}]}, {'title': 'Right Temporal Superior longitudinal fasciculus', 'categories': [{'measurements': [{'value': '0.3460', 'spread': '0.1647', 'groupId': 'OG000'}, {'value': '0.3338', 'spread': '0.1251', 'groupId': 'OG001'}, {'value': '0.3340', 'spread': '0.1574', 'groupId': 'OG002'}, {'value': '0.3330', 'spread': '0.1592', 'groupId': 'OG003'}]}]}, {'title': 'Left Corticospinal tract', 'categories': [{'measurements': [{'value': '0.3909', 'spread': '0.1860', 'groupId': 'OG000'}, {'value': '0.3790', 'spread': '0.1418', 'groupId': 'OG001'}, {'value': '0.3826', 'spread': '0.1804', 'groupId': 'OG002'}, {'value': '0.3800', 'spread': '0.1812', 'groupId': 'OG003'}]}]}, {'title': 'Right Corticospinal tract', 'categories': [{'measurements': [{'value': '0.3870', 'spread': '0.1841', 'groupId': 'OG000'}, {'value': '0.3766', 'spread': '0.1407', 'groupId': 'OG001'}, {'value': '0.3802', 'spread': '0.1792', 'groupId': 'OG002'}, {'value': '0.3780', 'spread': '0.1802', 'groupId': 'OG003'}]}]}, {'title': 'Left cingulate gyrus', 'categories': [{'measurements': [{'value': '0.3831', 'spread': '0.1826', 'groupId': 'OG000'}, {'value': '0.3697', 'spread': '0.1385', 'groupId': 'OG001'}, {'value': '0.3662', 'spread': '0.1726', 'groupId': 'OG002'}, {'value': '0.3652', 'spread': '0.1747', 'groupId': 'OG003'}]}]}, {'title': 'Right cingulate gyrus', 'categories': [{'measurements': [{'value': '0.3758', 'spread': '0.1789', 'groupId': 'OG000'}, {'value': '0.3647', 'spread': '0.1364', 'groupId': 'OG001'}, {'value': '0.3705', 'spread': '0.1747', 'groupId': 'OG002'}, {'value': '0.3662', 'spread': '0.1751', 'groupId': 'OG003'}]}]}, {'title': 'Left Uncinate fasciculus', 'categories': [{'measurements': [{'value': '0.3219', 'spread': '0.1533', 'groupId': 'OG000'}, {'value': '0.3136', 'spread': '0.1177', 'groupId': 'OG001'}, {'value': '0.3104', 'spread': '0.1464', 'groupId': 'OG002'}, {'value': '0.3057', 'spread': '0.1463', 'groupId': 'OG003'}]}]}, {'title': 'Right Uncinate fasciculus', 'categories': [{'measurements': [{'value': '0.3231', 'spread': '0.1538', 'groupId': 'OG000'}, {'value': '0.3120', 'spread': '0.1172', 'groupId': 'OG001'}, {'value': '0.3148', 'spread': '0.1484', 'groupId': 'OG002'}, {'value': '0.3073', 'spread': '0.1470', 'groupId': 'OG003'}]}]}, {'title': 'Left Inferior longitudinal fasciculus', 'categories': [{'measurements': [{'value': '0.3552', 'spread': '0.1692', 'groupId': 'OG000'}, {'value': '0.3388', 'spread': '0.1269', 'groupId': 'OG001'}, {'value': '0.3408', 'spread': '0.1607', 'groupId': 'OG002'}, {'value': '0.3421', 'spread': '0.1636', 'groupId': 'OG003'}]}]}, {'title': 'Right Inferior longitudinal fasciculus', 'categories': [{'measurements': [{'value': '0.3522', 'spread': '0.1677', 'groupId': 'OG000'}, {'value': '0.3392', 'spread': '0.1272', 'groupId': 'OG001'}, {'value': '0.3399', 'spread': '0.1603', 'groupId': 'OG002'}, {'value': '0.3393', 'spread': '0.1621', 'groupId': 'OG003'}]}]}, {'title': 'Left Hippocampus', 'categories': [{'measurements': [{'value': '0.3572', 'spread': '0.1705', 'groupId': 'OG000'}, {'value': '0.3464', 'spread': '0.1300', 'groupId': 'OG001'}, {'value': '0.3493', 'spread': '0.1649', 'groupId': 'OG002'}, {'value': '0.3441', 'spread': '0.1645', 'groupId': 'OG003'}]}]}, {'title': 'Right Hippocampus', 'categories': [{'measurements': [{'value': '0.3750', 'spread': '0.1786', 'groupId': 'OG000'}, {'value': '0.3677', 'spread': '0.1377', 'groupId': 'OG001'}, {'value': '0.3617', 'spread': '0.1706', 'groupId': 'OG002'}, {'value': '0.3635', 'spread': '0.1737', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Fractional Anisotropy (FA) is a scalar metric derived from diffusion-weighted MRI that quantifies the degree of directional dependence (anisotropy) of water diffusion in brain white matter, with values ranging from 0 (isotropic diffusion) to 1 (maximally anisotropic diffusion). Increases in FA may reflect greater white matter organization and integrity, while decreases often indicate microstructural damage, demyelination, or axonal loss. FA measurements were averaged within predefined regions of interest (ROIs) to assess the integrity of white matter in various brain regions associated with cognitive, motor, and emotional processing. Decreased FA in tracts such as the corpus callosum or prefrontal pathways may reflect impaired communication between brain regions involved in reward processing and cognitive control in substance use disorders.', 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were removed from analysis due to too much motion, performing the task incorrectly, or did not perform the task during the MRI session.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'FG001', 'title': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'FG002', 'title': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'FG003', 'title': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}], 'periods': [{'title': 'Screening Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Screen fail after consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}, {'title': 'Baseline Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Check-In Visit (Alcohol Groups Only)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Deemed no longer eligible due to changes in health', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Follow-up Visit (Alcohol Groups Only)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Could not complete in-person items due to COVID-19 shutdown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted in a hospital setting from 2018 to 2023.', 'preAssignmentDetails': "Of 616 phone screens conducted at the VA Portland Health Care System, 171 were eligible to participate in the study, and 109 participants signed an informed consent form. 4 participants were screened out or declined participation after consent but prior to any data collection and are not included in participant flow table. Control and Nicotine group's participation was complete after baseline measurements were collected. Alcohol groups continued to next periods."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'BG001', 'title': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'BG002', 'title': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'BG003', 'title': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.\n\nmagnetic resonance imaging (MRI): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.86', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '38.67', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '41.45', 'spread': '6.8', 'groupId': 'BG002'}, {'value': '40.88', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '38.41', 'spread': '9.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who screened out or were lost to follow up during the screening visit are not included in baseline analysis population reporting.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-01', 'size': 773309, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-07T13:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cheek swab Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2017-11-06', 'resultsFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-11', 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Activation During Functional Magnetic Resonance Imaging (fMRI) in Response to a Stress Modulated Cue Induced Craving Task (DSNBACK)', 'timeFrame': 'Baseline', 'description': 'The DSN-back is a cognitive task used to assess working memory and attention. Participants view a sequence of letters presented on a screen, flanked by either drug-related or neutral images, and are instructed to identify matches occurring N steps earlier. Neural activation during high working memory demand condition (2-back) relative to the low working memory condition (0-back) was investigated. Inconsistent activation patterns across regions may indicate impaired neural processing in regions critical for cognitive control, emotion regulation, and reward processing, commonly reported in substance use disorders. Values closer to 0 (no change) in regions responsible for emotion regulation and cognitive control (e.g., Amygdala, ACC) may indicate reduced task-specific engagement where drug-related processes may be dominating neural activity.'}, {'measure': 'Brain Activation During Resting State MRI.', 'timeFrame': 'Baseline', 'description': 'This outcome measures resting-state functional connectivity (rsFC) of the striatum using seed-based analysis of resting-state fMRI data. FC values, expressed as Fisher z-transformed correlation coefficients, quantify the strength of synchronization between the striatum seed region and other brain areas. Positive values indicate synchronized activity, while negative values reflect anticorrelation. Altered rsFC of the striatum, a hub for reward processing, habit formation, and executive control, is linked to alcohol and nicotine use disorders and may indicate impaired regulation of cravings and heightened sensitivity to substance-related cues. Investigating rsFC patterns may identify biomarkers of addiction severity, predict treatment outcomes, and inform potential therapeutic targets.'}, {'measure': 'Brain Cortical Thickness Assessed During MRI', 'timeFrame': 'Baseline', 'description': 'This outcome measures cortical thickness (millimeters) across brain regions using structural MRI. Cortical thickness reflects the integrity of gray matter and is influenced by factors such as neurodegeneration, plasticity, and development. Reductions in cortical thickness, particularly in prefrontal and limbic regions, are associated with impaired cognitive control, emotion regulation, and decision-making in substance use disorders.'}, {'measure': 'Brain White Matter Integrity as Assessed by Fractional Anisotropy During MRI', 'timeFrame': 'Baseline', 'description': 'Fractional Anisotropy (FA) is a scalar metric derived from diffusion-weighted MRI that quantifies the degree of directional dependence (anisotropy) of water diffusion in brain white matter, with values ranging from 0 (isotropic diffusion) to 1 (maximally anisotropic diffusion). Increases in FA may reflect greater white matter organization and integrity, while decreases often indicate microstructural damage, demyelination, or axonal loss. FA measurements were averaged within predefined regions of interest (ROIs) to assess the integrity of white matter in various brain regions associated with cognitive, motor, and emotional processing. Decreased FA in tracts such as the corpus callosum or prefrontal pathways may reflect impaired communication between brain regions involved in reward processing and cognitive control in substance use disorders.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder', 'Nicotine Use Disorder']}, 'descriptionModule': {'briefSummary': 'This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users.', 'detailedDescription': 'This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users. AUD and nicotine use disorder (NUD) are the most commonly abused (non-prescription) substances in the U.S. Co-addiction is particularly high in military veterans. Although nationwide estimates peg the rate of AUD/NUD co-addiction at 80%, the Substance Abuse Treatment Program (SATP) at the Veterans Affairs Portland Health Care System (VAPORHCS) finds that 90% of veterans treated for AUD also meet criteria for NUD. The investigators hypothesize that a support vector machine learning algorithm will be able to use the measures to classify subjects as AUD, NUD both or neither and that the algorithm will predict outcome (sobriety or relapse) at three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from the Portland VA, Oregon Health \\& Science University, community substance abuse treatment programs and by advertisement.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* None\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03338933', 'acronym': 'NAUD', 'briefTitle': 'Neurobiology of Alcohol and Nicotine Co-Addiction', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Neurobiology of Alcohol and Nicotine Co-Addiction', 'orgStudyIdInfo': {'id': 'NURA-002-17S'}, 'secondaryIdInfos': [{'id': '17321', 'type': 'OTHER', 'domain': 'Oregon Health and Science University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.', 'interventionNames': ['Behavioral: magnetic resonance imaging (MRI)']}, {'label': 'Nicotine Group', 'description': 'Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance', 'interventionNames': ['Behavioral: magnetic resonance imaging (MRI)']}, {'label': 'Nicotine and Alcohol Group', 'description': 'DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.', 'interventionNames': ['Behavioral: magnetic resonance imaging (MRI)']}, {'label': 'Alcohol Group', 'description': 'DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.', 'interventionNames': ['Behavioral: magnetic resonance imaging (MRI)']}], 'interventions': [{'name': 'magnetic resonance imaging (MRI)', 'type': 'BEHAVIORAL', 'description': 'All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.', 'armGroupLabels': ['Alcohol Group', 'Control Group', 'Nicotine Group', 'Nicotine and Alcohol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97207-2964', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'William F Hoffman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Portland Health Care System, Portland, OR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}