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NOT YET RECRUITING

NCT06722898

PHASE2

Rapid BAC Reduction with Nutraceutical Blend Study

Sponsor: Medical Life Care Planners, LLC

View on ClinicalTrials.gov

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 \&amp;amp;lt;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.

Official title: Rapid Blood Alcohol Concentration Reduction with Nutraceutical Blend Study

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-01

Completion Date

2025-02-07

Last Updated

2024-12-09

Healthy Volunteers

Yes

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

The Warehouse St. Pete

St. Petersburg, Florida, United States