Nutritional Supplement for Hangover Symptoms
Trial Summary
What is the purpose of this trial?
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 S80™ breathalyzer) Cognitive/physical impairment change (DRUID app™) 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.
Research Team
Gregory L Smith, MD, MPH
Principal Investigator
NeX Therapeutics
Eligibility Criteria
This trial is for individuals who frequently consume alcohol and experience hangovers. Participants must be healthy, within a specific age range, and not pregnant. They should have no history of alcoholism or liver disease, and agree to follow the study's protocol including Uber transportation after sessions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume alcohol and receive either the nutraceutical or placebo, with BAC and impairment measurements taken
Follow-up
Participants are monitored for hangover symptoms the morning after each session
Treatment Details
Interventions
- Nutritional Supplement
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Who Is Running the Clinical Trial?
Medical Life Care Planners, LLC
Lead Sponsor