Rapid BAC Reduction with Nutraceutical Blend Study

Summary

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.

Conditions

• Alcohol Consumption
• Alcohol
• Hangover Symptoms, NAC
• Veisalgia

Interventions

DIETARY_SUPPLEMENT

Supplement

Contains ingredients believed to reduce Blood Alcohol Concentration and symptoms of alcohol impairment.

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

• Medical Life Care Planners, LLC

  lead OTHER

Principal Investigators

• Gregory L Smith, MD, MPH · NeX Therapeutics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2025-02-01

Completion

2025-02-07

Countries

• United States

Study Locations