[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618500":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":41,"locations":51,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":40,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":40,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":105,"whyStopped":40,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Galzu Institute of Research, Teaching, Science and Applied Technology","OTHER",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Alcovit (Pre-consumption)","EXPERIMENTAL","Participants receive the investigational device immediately before (2-3 minutes) consuming the standardized alcohol dose.",[13],"Device: Alcovit® (Zeolite Clinoptilolite)",{"label":15,"type":10,"description":16,"interventionNames":17},"Alcovit (Post-consumption)","Participants receive the investigational device immediately after (maximum 5 minutes) consuming the standardized alcohol dose.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo (Pre-consumption)","PLACEBO_COMPARATOR","Participants receive the placebo immediately before consuming the standardized alcohol dose.",[23],"Device: Placebo",{"label":25,"type":20,"description":26,"interventionNames":27},"Placebo (Post-consumption)","Participants receive the placebo immediately after consuming the standardized alcohol dose.",[23],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Alcovit® (Zeolite Clinoptilolite)","Effervescent powder for oral suspension presented in 15g sachets, containing zeolite clinoptilolite (approximately 96% of the formulation) associated with B-complex vitamins (B1, B6, B12), vitamin C, and cupric chlorophyllin as natural colorant. The device is administered either immediately before alcohol consumption (2-3 minutes prior) or immediately after alcohol consumption (maximum 5 minutes after) depending on the assigned study arm.",[15,9],[9,15],{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Placebo","Effervescent powder for oral suspension presented in 15g sachets. Inert substance with identical appearance, taste, and texture to Alcovit®, but without the active ingredient (zeolite clinoptilolite). The placebo is administered either immediately before alcohol consumption (2-3 minutes prior) or immediately after alcohol consumption (maximum 5 minutes after) depending on the assigned study arm.",[25,19],[19,25],null,[42,47],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Marcelo P Coutinho, MD, PhD","CONTACT","+55 22 992266669","coutinho_doc@hotmail.com",{"name":48,"role":44,"phone":49,"phoneExt":40,"email":50},"Savio B Souza, PhD","+55 22 999857370","institutogalzu@galzu.org.br",[52],{"facility":53,"status":40,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Hospital Santa Casa de Misericórdia de Campos","Campos dos Goytacazes","Rio de Janeiro","28035-053","Brazil","BR",{"type":60,"coordinates":61},"Point",[62,63],-41.33044,-21.75227,{"lat":63,"lon":62},[66],{"name":67,"role":44,"phone":68,"phoneExt":40,"email":69},"Ailton X Silva, MD","+55 22 99985-7370","instiutogalzu@galzu.org.br",{"type":71,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[73],{"name":74,"class":75},"Hospital Santa Casa de Misericordia de Campos","UNKNOWN","100618500","efficacy-and-safety-of-alcovit-in-reducing-blood-alcohol-concentration-100618500",false,"NCT07332429","Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration","Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals","Inclusion Criteria:\n\n* Healthy adults aged 18 to 70 years;\n* Occasional or moderate alcohol consumers;\n* Willing to abstain from alcohol and Alcovit® for a period established in the study;\n* Voluntary willingness to participate in the study and sign the Informed Consent Form (ICF);\n* Availability to comply with the study schedule.\n\nExclusion Criteria:\n\n* History of alcohol use disorder (alcoholism) or abuse of other illicit substances;\n* Hepatic, renal, gastrointestinal diseases, diabetes, and chronic conditions;\n* Use of medications that interact with alcohol, including but not limited to: non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac, naproxen), analgesics, antibiotics, antidepressants, benzodiazepines, anticoagulants, or any other medication that may interfere with alcohol metabolism or increase risks associated with alcohol consumption;\n* Pregnancy or breastfeeding (beta-hCG test will be performed);\n* Known allergy to any component of Alcovit® or placebo;\n* Patients already enrolled in other clinical trials;\n* Inability to provide free and informed consent;\n* Any clinically significant medical condition or medical history that, in the investigator's opinion, may discourage participation in the study.",true,"ALL","18 Years","70 Years",{"count":88,"type":89},228,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to learn if Alcovit® (zeolite clinoptilolite) works to reduce blood alcohol concentration in healthy adults aged 18-70 years who are occasional or moderate alcohol consumers. It will also learn about the safety and tolerability of Alcovit®. The main questions it aims to answer are:\n\n* Does Alcovit® reduce blood alcohol concentration when administered before or after standardized alcoholic beverage consumption compared to placebo?\n* What is the rate of alcohol elimination from the blood (mg\u002FdL\u002Fhour) in participants taking Alcovit® compared to placebo?\n* Is Alcovit® well tolerated when administered before or after alcohol consumption?\n\nResearchers will compare Alcovit® administered before alcohol consumption, Alcovit® administered after alcohol consumption, placebo administered before alcohol consumption, and placebo administered after alcohol consumption to see if Alcovit® effectively reduces blood alcohol levels.\n\nParticipants will:\n\n* Consume a standardized alcoholic beverage under controlled conditions;\n* Take Alcovit® or a placebo either 2-3 minutes before or after (within 5 minutes) alcohol consumption;\n* Have blood samples collected at baseline (30 minutes before), and at 20, 40, and 60 minutes after alcohol consumption to measure blood alcohol concentration;\n* Complete breathalyzer (etilometer) measurements at the same time points;\n* Answer questionnaire to assess alcohol hangover severity;\n* Have safety blood tests performed to monitor liver and kidney function.",[95,96,97],"Alcohol Drinking","Blood Alcohol Content","Hangover",[99,100,101,102,103,104],"Zeolite Clinoptilolite","Alcovit","Alcohol Absorption","Medical Device","Hangover Prevention","Blood Alcohol Concentration","NOT_YET_RECRUITING","2026-01-09",{"date":108,"type":109},"2026-01-12","ACTUAL",{"date":111,"type":89},"2026-05-30",{"date":113,"type":89},"2027-05-30",{"name":5,"class":6},1]