Rapid Blood Alcohol Concentration Reduction with Nutraceutical Blend Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Blood Alcohol Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Blood Alcohol Concentration
时间窗: 90 minutes
The first primary outcome measure will be the rate and extent of Blood Alcohol Concentration (BAC) reduction due to the effects of administering BAC Down™ after excessive consumption of alcohol, tested using a BACtrack S80™ (US FDA 501(k)) advanced technology breathalyzer.
Alcohol Impairment
时间窗: 90 minutes
The second primary outcome measure will be change in cognitive/physical impairment due to the effects of administering BAC Down™ after excessive alcohol consumption. The DRUID app™ will be used to measure cognitive and motor impairment. Each subject will have a standard training session with the use of the DRUID app on their phone.
次要结局
- Reduction of Hangover Symptoms(12-24 hours after study completion)
研究者
Gregory L Smith, MD, MPH
Primary Investigator
Medical Life Care Planners, LLC