Not Yet RecruitingNot Applicable

Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

Brazil228 participantsStarted 2026-05-30

Plain-language summary

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: * Does Alcovit® reduce blood alcohol concentration when administered before or after standardized alcoholic beverage consumption compared to placebo? * What is the rate of alcohol elimination from the blood (mg/dL/hour) in participants taking Alcovit® compared to placebo? * Is Alcovit® well tolerated when administered before or after alcohol consumption? Researchers 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. Participants will: * Consume a standardized alcoholic beverage under controlled conditions; * Take Alcovit® or a placebo either 2-3 minutes before or after (within 5 minutes) alcohol consumption; * Have blood samples collected at baseline (30 minutes before), and at 20, 40, and 60 minutes after alcohol consumption to measure blood alcohol concentration; * Complete breathalyzer (etilometer) measurements at the same time points; * Answer questionnaire to assess alcohol hangover severity; * Have safety blood tests performed to monitor liver and kidney function.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy adults aged 18 to 70 years; * Occasional or moderate alcohol consumers; * Willing to abstain from alcohol and Alcovit® for a period established in the study; * Voluntary willingness to participate in the study and sign the Informed Consent Form (ICF); * Availability to comply with the study schedule. Exclusion Criteria: * History of alcohol use disorder (alcoholism) or abuse of other illicit substances; * Hepatic, renal, gastrointestinal diseases, diabetes, and chronic conditions; * 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; * Pregnancy or breastfeeding (beta-hCG test will be performed); * Known allergy to any component of Alcovit® or placebo; * Patients already enrolled in other clinical trials; * Inability to provide free and informed consent; * Any clinically significant medical condition or medical history that, in the investigator's opinion, may discourage participation in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Blood Alcohol Levels and Breathalyzer Readings - Pre-consumption Administration

Timeframe: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)

Reduction in Blood Alcohol Levels and Breathalyzer Readings - Post-consumption Administration

Timeframe: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).

Trial details

NCT IDNCT07332429

SponsorGalzu Institute of Research, Teaching, Science and Applied Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

Contact for this trial

Marcelo P Coutinho, MD, PhD

+55 22 992266669 coutinho_doc@hotmail.com

View on ClinicalTrials.gov More Alcohol Drinking trials