Rapid BAC Reduction with Nutraceutical Blend Study

Официальное название

Rapid Blood Alcohol Concentration Reduction with Nutraceutical Blend Study

Обзор

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.

Подробное описание

Study Title: Nutraceutical Safety and Efficacy Study

Introduction:

The nutraceutical Safety and Efficacy Study is a comprehensive clinical trial designed to evaluate a novel formulation aimed at rapidly decreasing blood alcohol concentration (BAC), alcohol-induced impairment, and veisalgia (hangover) symptoms following excessive alcohol consumption. This study addresses a significant public health concern by potentially offering a method to mitigate the negative effects of alcohol overconsumption.

Study Design:

This is a triple-blinded, randomized, placebo-controlled clinical trial. The triple-blind nature ensures that the subjects, investigators, and data analysts are unaware of the treatment assignments, minimizing bias in the results.

Primary Objectives:

To determine the rate and extent of BAC reduction after administration of nutraceutical compared to placebo.

To assess the change in cognitive and physical impairment due to nutraceutical supplement after excessive alcohol consumption.

Secondary Objective:

To evaluate the reduction in hangover symptoms the morning after excessive alcohol consumption when active compared to placebo.

Study Population:

The study will recruit 70 subjects (35 per arm) from the Tampa Bay area through social media. Key inclusion criteria include:

Age 21 or older Regular social alcohol use Not naive to consuming more than 4 drinks at once Ability to attend all three sessions Ownership of a smartphone with texting capabilities

Exclusion criteria encompass:

Alcohol Use Disorder (AUDIT score ≥8) Use of certain medications (e.g., Antabuse, beta-lactam antibiotics) Current use of psychoactive products or illegal substances Active medical conditions precluding excessive alcohol use Pregnancy or unknown pregnancy status Current involvement in the criminal justice system

Study Duration and Timeline:

The study will span 4 weeks, with three testing sessions scheduled on Sundays: August 15th, August 22nd, and October 5th, 2024. Each session will last approximately 4 hours, from 4 PM to 8 PM. The final statistical analysis and preparation for journal submission are expected to be completed by early November 2024.

Study Location:

All sessions will be conducted at a centrally located closed bar in St. Petersburg, FL, ensuring a controlled environment for the study.

Intervention:

The study will test two formulations:

Capsule form Mini-drink form

Each formulation will be compared against a matching placebo. The active ingredients and placebos will be provided. The exact composition is proprietary, but it consists of Generally Recognized as Safe (GRAS) ingredients.

Study Procedure:

Each subject will participate in three sessions, receiving either the active formulation or placebo in a randomized order. The procedure for each session is as follows:

Subjects arrive and consume a standardized meal (one slice of pizza or equivalent).

Baseline measurements are taken (BAC and impairment tests). Subjects consume a 20 oz container of vodka and flavoring (1g ethanol per kg of body weight) over a 40-minute period.

Immediately after drinking, BAC is measured, and impairment tests are conducted.

Subjects receive either the active formulation or placebo. BAC measurements are taken at 15, 30, 60, and 90 minutes post-drinking. Impairment tests are conducted at 15, 30, and 60 minutes post-drinking. Subjects remain at the facility until their BAC is below 0.08%, then are provided Uber transportation home.

The following morning at 8 AM, subjects complete a hangover questionnaire via text message.

Outcome Measures:

Blood Alcohol Concentration (BAC):

Instrument: BACtrack S80™ breathalyzer (US FDA 510(k) approved) Measurement points: Baseline, immediately after drinking (40 minutes), then at 15, 30, 60, and 90 minutes post-drinking Analysis: Rate and extent of BAC reduction compared to placebo

Cognitive and Physical Impairment:

Primary instrument: DRUID app™

Secondary measures:

1. Horizontal Gaze Nystagmus (HGN) test 2. One-leg Stand test 3. Computer-assisted testing for reaction time, sustained attention, and decision making (www.HumanBenchMark.com) Measurement points: Baseline, 15, 30, and 60 minutes post-drinking Analysis: Change in impairment scores compared to placebo

Hangover Symptoms:

Instrument: Acute Hangover Scale (AHS™) Description: 9-question survey, rating symptoms on a scale of 0-7 Administration: Via text message at 8 AM the morning after each session Analysis: Comparison of hangover symptom scores between and placebo conditions

Safety Measures:

Вмешательства

• Пищевая добавка Supplement
  Contains ingredients believed to reduce Blood Alcohol Concentration and symptoms of alcohol impairment.
• Пищевая добавка Placebo
  Placebo

Первичные конечные точки

• Blood Alcohol Concentration [Срок оценки: 90 minutes]
• Alcohol Impairment [Срок оценки: 90 minutes]

Вторичные конечные точки (1)

• Reduction of Hangover Symptoms [Срок оценки: 12-24 hours after study completion]

Критерии участия

Критерии включения

• Over age 21
• Provide signed Informed Consent form electronically in advance of the first study date.
• Provided signed Acknowledgement Form of what is required as part of the study, including use of Uber for transportation to and from each session.
• Not taking certain prescription medications to be listed.
• No history of alcohol or substance abuse issues or alcohol-related medical conditions.
• No history of liver disease.
• No history of significant violent behavior.
• Uses alcohol socially on a regular basis.
• Not naïve to consuming more than 4 drinks at one time.
• Not pregnant or at risk for being pregnant.
• Able to attend all three session dates.
• Own smartphone with text messaging abilities.

Критерии исключения

• Score consistent with Alcohol Use Disorder on the Alcohol Use Disorder Identification Test (AUDIT) a 10 question self-report tool developed by the World Health Organization (WHO).
• Ongoing or regular use of any of the following medications for medical conditions: Antabuse (disulfiram): (Slows alcohol metabolism by inhibiting the elimination of acetaldehyde), Beta-lactam antibiotics: (Some, such as cefmandole, cefoperazone, and moxalactam, can cause a disulfiram-like reaction when alcohol is consumed), Nitrates (Can cause a disulfiram-like reaction when alcohol is consumed), Sulfonylureas (Longer acting ones, such as chlorpropamide and tolbutamide, can cause a disulfiram-like reaction when alcohol is consumed, as well as Pyrazoles and isobutyramide, Inhibit ADH, which decreases the rate at which alcohol is eliminated.)
• Current use of medications likely to be synergistic with one-time excessive use of alcohol: opioids, benzodiazepines, anti-histamines.
• Current use of psychoactive products such as delta 8 or delta 9 tetrahydrocannabinol (THC), Kava, Kratom or psychedelic mushroom (psilocybin).
• Current use of any illegal drug or substance, that includes, but is not limited to -cocaine, methamphetamine, MDMA (ecstasy, molly).
• Active medical conditions that would preclude one-time excessive use of alcohol: Liver disease, diabetes mellitus, seizure disorder/epilepsy, uncontrolled hypertension, cardiac arrhythmia, Multiple Sclerosis, Schizophrenia, Traumatic Brain Injury (TBI), active peptic ulcer disease (PUD), and opioid use disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Warehouse St. Pete — St. Petersburg

Идентификаторы

NCT: NCT06722898 · 000011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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