Rapid BAC Reduction with Nutraceutical Blend Study (NCT06722898)
Rapid Blood Alcohol Concentration Reduction with Nutraceutical Blend Study
๐ฉบ Plain-English Summary (8th-Grade Level)
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. Primary Outcomes: BAC reduction rate/extent (BACtrack S80โข breathalyzer) Cognitive/physical impairment change (DRUID appโข) Secondary Outcome: Hangover 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 Procedure: Subjects consume standardized alcohol (1g ethanol/kg body weight) 40-minute drinking period BAC and impairment measurements Administration of test formulation or placebo Measurements: BAC: Baseline, 40min, 15min, 30min, 60min, 90min post-drinking Impairment: Baseline, 15min, 30min, 60min post-drinking Hangover: Next morning via text message Safety Measures: GRAS ingredients Lab testing of formulations Medical screening Adverse effect questionnaires Pregnancy tests BAC \<0.08% before leaving Key Features: Paired measurements: active vs. placebo for mini-drink and capsule formulations Uber transportation provided Strict inclusion/exclusion criteria Data Analysis: Electronic data entry Blinded submission for statistical analysis Paired comparisons and multiple statistical tests This 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.
Who can join: Review the eligibility criteria below.
Location: The Warehouse St. Pete โ St. Petersburg, Florida
Age range: 21 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- The Warehouse St. Pete โ St. Petersburg, Florida
๐ Contact the Study Coordinator
Phone: (404) 451-4045
Email: disabilityevaluators@gmail.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.