[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656392":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":56,"studyPopulation":53,"armGroups":57,"interventions":65,"overallOfficials":75,"centralContacts":79,"locations":85,"responsibleParty":103,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":53,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":53,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":88,"whyStopped":53,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":33},[9,13,16,18,21,23],{"measure":10,"description":11,"timeFrame":12},"Dorsolateral prefrontal cortex [F-18]BCPP-EF VT","VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL\u002Fcm3","Baseline scan (time 0)",{"measure":14,"description":15,"timeFrame":12},"Orbitofrontal cortex [F-18]BCPP-EF VT","VT is the volume of distribution expressed relative to total plasma radioligand concentration in mL\u002Fcm3",{"measure":17,"description":11,"timeFrame":12},"Medial Prefrontal Cortex [F-18]BCPP-EF VT",{"measure":19,"description":20,"timeFrame":12},"Dorsolateral prefrontal cortex [F-18]FDG SUVR","SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless",{"measure":22,"description":20,"timeFrame":12},"Orbitofrontal cortex [F-18]FDG SUVR",{"measure":24,"description":20,"timeFrame":12},"Medial Prefrontal Cortex [F-18]FDG SUVR",[26,30],{"measure":27,"description":28,"timeFrame":29},"Relapse to alcohol severity measure","Total number of ETG-negative urines (0 to 16)","during 8-week follow up",{"measure":31,"description":32,"timeFrame":29},"Penn Alcohol Craving Scale (PACS)","Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving)",[34,38,42,45],{"measure":35,"description":36,"timeFrame":37},"Categorical relapse to alcohol","Abstained v Relapsed v Drop-out","8-week follow up",{"measure":39,"description":40,"timeFrame":41},"TIme to relapse","in weeks (0 to 8)","during 8 week follow up",{"measure":43,"description":44,"timeFrame":29},"Perceived Stress Scale (PSS)","Mean weekly PSS scores (0 to 40; higher scores indicate more stress)",{"measure":46,"description":47,"timeFrame":12},"Prefrontal Cortical Thickness","MRI-derived cortical thickness measure derived using FreeSurfer, in mm",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":53,"timePerspective":53,"maskingInfo":54},"NA","SINGLE_GROUP","AUD and HC will receive the same intervention","BASIC_SCIENCE",null,{"masking":55,"maskingDescription":53,"whoMasked":53},"NONE","This study uses \\[18F\\]BCPP-EF and \\[18F\\]FDG positron emission tomography (PET) to image mitochondrial complex I and cerebral glucose metabolism (CGM) in subjects with alcohol use disorder (AUD) and healthy controls (HC). Correlating PET outcome measures with relapse to alcohol in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.",[58],{"label":59,"type":60,"description":61,"interventionNames":62},"PET","EXPERIMENTAL","Positron Emission Tomography Scans",[63,64],"Drug: [F-18]BCPP-EF","Drug: [F-18]FDG",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":53},"DRUG","[F-18]BCPP-EF","Radiotracer to measure binding to mitochondria complex -I",[59],{"type":67,"name":72,"description":73,"armGroupLabels":74,"otherNames":53},"[F-18]FDG","Radiotracer to measure cerebral glucose metabolism",[59],[76],{"name":77,"affiliation":5,"role":78},"Rajesh Narendran, MD","PRINCIPAL_INVESTIGATOR",[80],{"name":81,"role":82,"phone":83,"phoneExt":53,"email":84},"Rajesh Narendran","CONTACT","412-647-5176","narendranr@upmc.edu",[86],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"University of PIttsburgh","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-79.99589,40.44062,{"lat":98,"lon":97},[101],{"name":102,"role":82,"phone":83,"phoneExt":53,"email":84},"Principal Investigator",{"type":104,"investigatorFullName":81,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"SPONSOR_INVESTIGATOR","Professor of Radiology and Psychiatry",[107],{"name":108,"class":109},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100656392","early-phase-1-imaging-mitochondrial-complex-i-in-alcohol-use-disorder-100656392",false,"NCT07825818","Imaging Mitochondrial Complex-I in Alcohol Use Disorder","Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)","Alcohol use disorders (AUD)\n\n1. Males or females between 18 and 55 years old\n2. fulfill DSM-5 criteria for alcohol use disorder\n3. History of NIAAA heavy drinking (for males, routinely consuming more than 4 drinks on any day or more than 14 drinks per week; for females, routinely consuming more than 3 drinks on any day or more than 7 drinks per week) in the past 30 days\n4. No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current depressive disorders (unless they are related to alcohol intoxication, withdrawal, or an alcohol- induced mood disorder).\n5. No other DSM-5 substance use disorders including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. Subjects with moderate and severe DSM-5 cannabis and tobacco use disorder will also be excluded;\n6. Subjects not currently on psychotropic or medical medications that can influence binding to MC-I (e.g., metformin) or CGM (e.g., insulin, GLP-1 agonists), or increase the risks associated with an arterial line (e.g., warfarin, clopidogrel, aspirin, naproxen, ibuprofen, etc.).\n7. No medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson's disease, mild or major neurocognitive disorders, and mitochondrial disorders; CGM is altered in diabetes, severe hyperlipidemia, hypertension, obesity), increase the risks associated with blood sampling (anemia), or placement of an arterial line (history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis) for PET\n8. Not currently pregnant or breast-feeding\n9. Not currently employed as a radiation worker; or has participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous radioactive drug study \\[studies\\] and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of radiotracers\n10. No medical or psychiatric contraindications to undergo an MRI scan (such as ferromagnetic tattoos\u002Fpiercings, implants, medical equipment, history of gunshot, and claustrophobia).\n\nHealthy controls (HC)\n\n1. Males or females between 18 and 55 years old\n2. No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder\n3. No history of heavy drinking as defined using NIAAA criteria in the past year\n4. 5 to 10 above.",true,"ALL","18 Years","55 Years",{"count":122,"type":123},100,"ESTIMATED","INTERVENTIONAL",[126],"EARLY_PHASE1","Studies proposed in this application will image mitochondrial Complex-I (MCI-I) and cerebral glucose metabolism (CGM) in alcohol use disorder (AUD) and matched healthy controls",[129,130],"Alcohol Use Disorder (AUD)","Healthy Controls Group - Age and Sex-matched",[59,68,72,132],"Alcohol use disorder","2026-09-11",{"date":135,"type":136},"2026-09-17","ACTUAL",{"date":138,"type":123},"2026-09-30",{"date":140,"type":123},"2032-12-31",{"name":81,"class":6},1]