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Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules\u002Fday Duration: 12 weeks\n\n\\+ Standard of Care: Medical Management.",[13],"Drug: N-acetyl cysteine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matched placebo\n\nGeneric name: dicalcium phosphate Strength: 600mg per capsule Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules\u002Fday Duration: 12 weeks.\n\n\\+ Standard of Care: Medical Management.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","N-acetyl cysteine","2400mg\u002Fday",[9],[27],"NAC",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Matched placebo",[15],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Kirsten Morley, PhD","CONTACT","61295153636","Kirsten.morley@sydney.edu.au",{"name":39,"role":35,"phone":31,"phoneExt":31,"email":40},"Paul Haber, MBBS","paul.haber@sydney.edu.au",[42,62,78],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Drug Health Services, Royal Prince Alfred Hospital","RECRUITING","Sydney","New South Wales","2050","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],151.20732,-33.86785,{"lat":54,"lon":53},[57,59],{"name":58,"role":35,"phone":31,"phoneExt":31,"email":37},"Kirsten Morley",{"name":60,"role":61,"phone":31,"phoneExt":31,"email":31},"Paul Haber","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":48,"countryCode":49,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Cornwall Street Medical Centre (UQ Health Care)","NOT_YET_RECRUITING","Annerley","Queensland","4103",{"type":51,"coordinates":69},[70,71],153.03248,-27.51228,{"lat":71,"lon":70},[74,77],{"name":75,"role":35,"phone":31,"phoneExt":31,"email":76},"Paul Clark, MBBS","paul.j.clark@uq.edu.au",{"name":75,"role":61,"phone":31,"phoneExt":31,"email":31},{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":48,"countryCode":49,"cosmosGeoPoint":84,"geoPoint":88,"contacts":31},"Turning Point","ACTIVE_NOT_RECRUITING","Richmond","Victoria","3121",{"type":51,"coordinates":85},[86,87],145.00176,-37.81819,{"lat":87,"lon":86},{"type":90,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[92],{"name":93,"class":6},"Monash University","100470621","phase-4-a-randomised-controlled-trial-of-n-acetylcysteine-for-the-management-of-alcohol-use-disorder-100470621",false,"NCT05408247","A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder","NAC-AUD","Inclusion Criteria:\n\n* Alcohol Use Disorder according to the DSM-V criteria\n* A desire to reduce or stop drinking\n* Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks\u002Fday for men; ≥4 for women) in the month prior to screening\n* Adequate cognition and English language skills to give valid consent and complete research interviews\n* Stable housing\n* Willingness to give written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary)\n* Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months)\n* Any substance dependence other than nicotine\n* Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation\n* Concurrent use of selenium, vitamin D or other anti-oxidants\n* Any alcohol pharmacotherapy within the past month","ALL","18 Years","70 Years",{"count":105,"type":106},280,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.",[112],"Alcohol Use Disorder (AUD)",[9,27,114,115],"Alcohol Dependence","N-acetylcysteine","2023-03-14",{"date":118,"type":119},"2023-03-16","ACTUAL",{"date":121,"type":119},"2023-02-16",{"date":123,"type":106},"2026-11",{"name":5,"class":6},3]