[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627708":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":31,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":31,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":31,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":31},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endotoxin","EXPERIMENTAL","Individuals with alcohol use disorder vs. control who receive a bolus dose of endotoxin (0.8 ng\u002Fkg of body weight).",[13],"Drug: Endotoxin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Individuals with alcohol use disorder vs. control matched to endotoxin at same volume of 0.9% saline solution.",[19],"Other: Placebo saline",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Bolus dose of 0.8 ng\u002Fkg",[9],[26],"Lipopolysaccharide",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo saline","Matched to endotoxin",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Lara Ray, PhD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","(310) 794-5383","lararay@psych.ucla.edu",{"name":42,"role":38,"phone":43,"phoneExt":31,"email":44},"Jessica Jenkins, MS","310-206-6756","jenkinsj@ucla.edu",{"type":35,"investigatorFullName":34,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Professor",[48],{"name":49,"class":50},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100627708","phase-2-endotoxin-exposure-to-examine-the-role-of-inflammation-in-alcohol-use-100627708",false,"NCT07452146","Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use","Understanding the Role of Inflammation in Alcohol Use Disorder: An Inflammatory Challenge Using Lipopolysaccharide","Inclusion Criteria (AUD Group):\n\n1. Be between the ages of 21 and 65\n2. Meet current (i.e., past month) DSM-5 diagnostic criteria for moderate to severe AUD\n3. Be non-treatment seeking for AUD\n4. Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent.\n5. Must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:\n\n   * Oral contraceptives\n   * Contraceptive sponge\n   * Patch\n   * Double barrier\n   * Intrauterine contraceptive device\n   * Etonogestrel implant\n   * Medroxyprogesterone acetate contraceptive injection\n   * Complete abstinence from sexual intercourse\n   * Hormonal vaginal contraceptive ring\n\nInclusion Criteria (Control Group):\n\n(1) The control group will be age-, sex-, smoking status-, and BMI-matched healthy individuals who drink at or below moderate drinking levels (≤1 drink\u002Fday for females, ≤2 drinks\u002Fday for males) and have no lifetime history of AUD.\n\nExclusion Criteria (All Groups):\n\n1. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine\n2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder\n3. Have current moderate to severe depression as indicated by a score of ≥ 21 on the Beck Depression Inventory - II (BDI-II)\n4. Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS)\n5. Have a positive urine screen for drugs other than cannabis;\n6. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)\n7. Have an intense fear of needles or have had any adverse reactions to needle puncture\n8. Be pregnant, nursing, or planning to become pregnant while taking part in the study\n9. Have a body mass index (BMI) greater than 30\n10. Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes, autoimmune or inflammatory disease)\n11. Have clinically significant abnormal EKG\n12. Have \\> Grade 2 laboratory abnormalities, based on FDA Guidance Document \"Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials\"\n13. Have any other circumstances that, in the opinion of the investigators, compromises participant safety\n14. To participate in the inflammatory challenge, participants must not show any of the following upon arrival to the inflammatory challenge study visit:\n\n    1. BrAC \\> 0.000 g\u002Fdl\n    2. clinical withdrawal (CIWA-R) score ≥ 10\n    3. blood pressure ≤ 90\u002F60 or ≥ 160\u002F120\n    4. resting pulse ≤ 50 beats\u002Fminute or \\> 100 beats\u002Fminute\n    5. temperature ≥ 99.5°F\n    6. recent (past 2 weeks) acute illness or vaccination\n    7. score of 10+ on Physical Sickness Symptoms Assessment",true,"ALL","21 Years","65 Years",{"count":63,"type":64},64,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","The study design consists of a randomized, double-blind, placebo-controlled study of low dose endotoxin. Individuals with current AUD (n=32) and matched controls without AUD (n=32) will be randomly assigned to receive a single intravenous (I.V.) infusion of either low dose endotoxin (0.8 ng\u002Fkg of body weight) or placebo (same volume of 0.9% saline solution) to determine the acute and protracted role of inflammation in alcohol use.",[70,71,72],"Alcohol Use Disorder","Inflammatory Response","Craving",[9],"NOT_YET_RECRUITING","2026-04-28",{"date":77,"type":78},"2026-05-04","ACTUAL",{"date":80,"type":64},"2026-06",{"date":82,"type":64},"2028-07",{"name":5,"class":6}]