Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration
Starting soon · Not applicable · Has a placebo group
Conditions studied: Alcohol Drinking, Blood Alcohol Content, Hangover
In brief
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.
Key facts
- Study ID
- NCT07332429
- Run by
- Galzu Institute of Research, Teaching, Science and Applied Technology
- People needed
- 228
- Starts
- 2026-05-30
- Expected to finish
- 2027-05-30
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hospital Santa Casa de Misericórdia de Campos — Campos dos Goytacazes, Rio de Janeiro, Brazil
Full record on ClinicalTrials.gov
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