Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03879759
Status:
UNKNOWN
Last Update Posted:
2019-03-19
First Post:
2019-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study 1: NAC vs Placebo (PL) (4 weeks outpatient) Study 2: NAC vs PL (3 days inpatient) Study 2: NAC vs PL (neuromaging session before vs after treatment)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2019-03-10', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study 1: Alcohol consumption', 'timeFrame': '4 weeks', 'description': 'as measured by the number of heavy drinking days per week and number of drinks per drinking day'}, {'measure': 'Study 1: Alcohol consumption', 'timeFrame': '4 weeks', 'description': 'as measured by the abstinence rate, time to relapse and time to lapse'}, {'measure': 'Study 2: Amount of Benzodiazepines administered', 'timeFrame': '3 days', 'description': 'as measured by the number of benzodiazepines administered in the NAC vs placebo groups'}, {'measure': 'Study 2: Amount of Benzodiazepines administered', 'timeFrame': '3 days', 'description': 'as measured by Alcohol Withdrawal Scale (AWS) score'}, {'measure': 'Study 2: Amount of Benzodiazepines administered', 'timeFrame': '3 days', 'description': 'as measured by Visual Analogue Scale (VAS) score'}, {'measure': 'Study 2: Amount of Benzodiazepines administered', 'timeFrame': '3 days', 'description': 'as measured by Alcohol Urge Questionaire (AUQ) Score'}, {'measure': 'Study 3: Markers of neural inflammation and responses to alcohol cue', 'timeFrame': '4 weeks', 'description': 'as measured by differences in cortical levels of glutathione'}, {'measure': 'Study 3: Markers of neural inflammation and responses to alcohol cue', 'timeFrame': '4 weeks', 'description': 'as measured by differences in cortical levels of N-acetylaspartate'}, {'measure': 'Study 3: Markers of neural inflammation and responses to alcohol cue', 'timeFrame': '4 weeks', 'description': 'as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation)'}], 'secondaryOutcomes': [{'measure': 'Alcohol craving', 'timeFrame': '4 weeks', 'description': 'as measured by Penn Alcohol Craving Scale (PACS) score'}, {'measure': 'Mood', 'timeFrame': '4 weeks', 'description': 'as measured by Depression Anxiety Stress Scale (DASS) score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Dependence']}, 'referencesModule': {'references': [{'pmid': '41128676', 'type': 'DERIVED', 'citation': 'Dunbar KY, Dali G, DeMayo MM, Logge W, Hurzeler T, Kelly C, Watt J, Squeglia LM, Kirkland AE, Haber PS, Morley KC. The Effect of N-Acetylcysteine (NAC) on Neurometabolites and Cognitive Function in Adults With Alcohol Use Disorder: A Preliminary Randomized Controlled Trial. Neuropsychopharmacol Rep. 2025 Dec;45(4):e70066. doi: 10.1002/npr2.70066.'}, {'pmid': '39102049', 'type': 'DERIVED', 'citation': 'Logge WB, Haber PS, Hurzeler TP, Towers EE, Morley KC. The effects of N-acetyl cysteine on intrinsic functional connectivity and neural alcohol cue reactivity in treatment-seeking individuals with alcohol use disorder: a preliminary study. Psychopharmacology (Berl). 2025 Jan;242(1):149-160. doi: 10.1007/s00213-024-06656-z. Epub 2024 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.', 'detailedDescription': 'Study 1: Relapse prevention: This is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive oral NAC (2400 mg: 2x 600mg tablets twice per day) or matching placebo. Trial participants will receive either oral NAC ( dose stated above) or matching placebo for up to 4 weeks.\n\nStudy 2: Withdrawal: Trial participants will receive oral NAC (dose stated above) or matching placebo within the first 24 hours of their admission for up to 3 days.\n\nStudy 3: Participants from the relapse prevention substudy will also receive 30-minute non-invasive brain imaging session prior to and after completing the treatment regime in Study 1.\n\nBoth males and females will be recruited for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol use disorder (this is an exclusion for the healthy control sample)\n* Able to understand and sign written informed consent\n* Must have a stable residence and be able to identify an individual who could locate subject if needed\n* Admitted for medical detoxification from alcohol (withdrawal study only)\n* Blood alcohol concentration of 0.00 (if completing brain imaging session)\n* Express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only)\n\nExclusion Criteria:\n\n* Clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern.\n* Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control\n* Women who are breastfeeding\n* Dependence on any substance other than nicotine\n* Court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only)\n* Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only)\n* Dependence on any substance other than nicotine\n\nThe following exclusion criteria are only applicable to participants undergoing the brain imaging session:\n\n* Extreme obesity\n* Pregnant or have any reason to believe they are pregnant;\n* Previous brain surgery;\n* Ever employed as a machinist, a welder or a metal worker;\n* Epilepsy\n* Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.'}, 'identificationModule': {'nctId': 'NCT03879759', 'briefTitle': 'The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'South West Sydney Local Health District'}, 'officialTitle': 'The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine for Alcohol Dependence: An Exploratory Pilot Study', 'orgStudyIdInfo': {'id': 'X17-0343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'NAC - Relapse Prevention (4 wks)', 'interventionNames': ['Drug: NAC 2400mg/day']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'NAC - Relapse Prevention (4 wks)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NAC 2400mg/day', 'type': 'DRUG', 'description': '2400mg/day 2 x 600mg b.d', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '4 matched placebo tablets/day', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kirsten M Morley, PhD', 'role': 'CONTACT', 'email': 'kirsten.morley@sydney.edu.au', 'phone': '+61295153636'}, {'name': 'Central Intake Line', 'role': 'CONTACT', 'email': 'sydneyalcoholtreatmentgroup@gmail.com', 'phone': '0459877108'}, {'name': 'Kirsten Morley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Drug Health Services, Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'centralContacts': [{'name': 'Kirsten Morley, PhD', 'role': 'CONTACT', 'email': 'kirsten.morley@sydney.edu.au', 'phone': '+61295153636'}], 'overallOfficials': [{'name': 'Paul S Haber, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sydney Local Health District'}, {'name': 'Andrew Baille, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Macquarie University'}, {'name': 'Kirsten Morley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sydney'}, {'name': 'Warren B Logge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sydney Local Health District'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South West Sydney Local Health District', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}, {'name': 'University of Sydney', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director', 'investigatorFullName': 'Professor Paul Haber', 'investigatorAffiliation': 'South West Sydney Local Health District'}}}}