[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571641":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":11,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Medical Life Care Planners, LLC","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR",null,[13],"Dietary Supplement: Placebo",{"label":15,"type":16,"description":11,"interventionNames":17},"Liquid","ACTIVE_COMPARATOR",[18],"Dietary Supplement: Supplement",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DIETARY_SUPPLEMENT","Supplement","Contains ingredients believed to reduce Blood Alcohol Concentration and symptoms of alcohol impairment.",[15],{"type":21,"name":9,"description":9,"armGroupLabels":26,"otherNames":11},[9],[28],{"name":29,"affiliation":30,"role":31},"Gregory L Smith, MD, MPH","NeX Therapeutics","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","4044514045","disabilityevaluators@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":11,"email":40},"Rachel Borch, BA","2077017091","rae@nex-therapeutics.com",[42],{"facility":43,"status":11,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Warehouse St. Pete","St. Petersburg","Florida","33712","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-82.67927,27.77086,{"lat":53,"lon":52},[56,57],{"name":11,"role":34,"phone":39,"phoneExt":11,"email":40},{"name":58,"role":34,"phone":11,"phoneExt":11,"email":11},"Rachel Borch",{"type":31,"investigatorFullName":29,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Primary Investigator","100571641","phase-2-rapid-bac-reduction-with-nutraceutical-blend-study-100571641",false,"NCT06722898","Rapid BAC Reduction with Nutraceutical Blend Study","Rapid Blood Alcohol Concentration Reduction with Nutraceutical Blend Study","Inclusion Criteria:\n\n* Over age 21\n* Provide signed Informed Consent form electronically in advance of the first study date.\n* Provided signed Acknowledgement Form of what is required as part of the study, including use of Uber for transportation to and from each session.\n* Not taking certain prescription medications to be listed.\n* No history of alcohol or substance abuse issues or alcohol-related medical conditions.\n* No history of liver disease.\n* No history of significant violent behavior.\n* Uses alcohol socially on a regular basis.\n* Not naïve to consuming more than 4 drinks at one time.\n* Not pregnant or at risk for being pregnant.\n* Able to attend all three session dates.\n* Own smartphone with text messaging abilities.\n\nExclusion Criteria:\n\n* Score consistent with Alcohol Use Disorder on the Alcohol Use Disorder Identification Test (AUDIT) a 10 question self-report tool developed by the World Health Organization (WHO).\n* Ongoing or regular use of any of the following medications for medical conditions: Antabuse (disulfiram): (Slows alcohol metabolism by inhibiting the elimination of acetaldehyde), Beta-lactam antibiotics: (Some, such as cefmandole, cefoperazone, and moxalactam, can cause a disulfiram-like reaction when alcohol is consumed), Nitrates (Can cause a disulfiram-like reaction when alcohol is consumed), Sulfonylureas (Longer acting ones, such as chlorpropamide and tolbutamide, can cause a disulfiram-like reaction when alcohol is consumed, as well as Pyrazoles and isobutyramide, Inhibit ADH, which decreases the rate at which alcohol is eliminated.)\n* Current use of medications likely to be synergistic with one-time excessive use of alcohol: opioids, benzodiazepines, anti-histamines.\n* Current use of psychoactive products such as delta 8 or delta 9 tetrahydrocannabinol (THC), Kava, Kratom or psychedelic mushroom (psilocybin).\n* Current use of any illegal drug or substance, that includes, but is not limited to -cocaine, methamphetamine, MDMA (ecstasy, molly).\n* Active medical conditions that would preclude one-time excessive use of alcohol: Liver disease, diabetes mellitus, seizure disorder\u002Fepilepsy, uncontrolled hypertension, cardiac arrhythmia, Multiple Sclerosis, Schizophrenia, Traumatic Brain Injury (TBI), active peptic ulcer disease (PUD), and opioid use disorder",true,"ALL","21 Years",{"count":72,"type":73},35,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","Study Title: Nutritional Supplement to Rapidly Decrease Blood Alcohol Concentration (BAC): Safety and Efficacy Study Design: Double-blind, randomized, placebo-controlled clinical trial Objective: Evaluate safety and efficacy of a nutritional supplement to rapidly decrease blood alcohol concentration (BAC), alcohol-induced impairment, and hangover symptoms after excessive alcohol consumption.\n\nPrimary Outcomes:\n\nBAC reduction rate\u002Fextent (BACtrack S80™ breathalyzer) Cognitive\u002Fphysical impairment change (DRUID app™)\n\nSecondary Outcome:\n\nHangover symptom reduction (Acute Hangover Scale) Participants: 35 participants, recruited via social media Duration: 2 weeks, 2 testing sessions (4 hours each) Location: Closed facility in St. Petersburg, FL\n\nProcedure:\n\nSubjects consume standardized alcohol (1g ethanol\u002Fkg body weight) 40-minute drinking period BAC and impairment measurements Administration of test formulation or placebo\n\nMeasurements:\n\nBAC: Baseline, 40min, 15min, 30min, 60min, 90min post-drinking Impairment: Baseline, 15min, 30min, 60min post-drinking Hangover: Next morning via text message\n\nSafety Measures:\n\nGRAS ingredients Lab testing of formulations Medical screening Adverse effect questionnaires Pregnancy tests BAC \\<0.08% before leaving\n\nKey Features:\n\nPaired measurements: active vs. placebo for mini-drink and capsule formulations Uber transportation provided Strict inclusion\u002Fexclusion criteria\n\nData Analysis:\n\nElectronic data entry Blinded submission for statistical analysis Paired comparisons and multiple statistical tests\n\nThis study aims to provide robust data on the efficacy in mitigating alcohol's effects, potentially offering a new tool for reducing alcohol-related impairment and hangover symptoms. The design prioritizes safety, consistency, and scientific rigor to ensure reliable results.",[79,80,81,82],"Alcohol Consumption","Alcohol","Hangover Symptoms, NAC","Veisalgia",[84,85,86,87,88,89,90,91,92,93],"alcohol","blood alcohol","alcohol intoxication","alcohol impairment","BAC","BAC reduction","alcohol half-life","blood alcohol concentration","veisalgia","hangover","NOT_YET_RECRUITING","2024-12-03",{"date":97,"type":98},"2024-12-09","ACTUAL",{"date":100,"type":73},"2024-12-01",{"date":102,"type":73},"2025-02-07",{"name":5,"class":6},1]