Health TrialsbyHealthPanel

Rapid BAC Reduction with Nutraceutical Blend Study

ConditionsAlcohol ConsumptionAlcoholHangover Symptoms, NACVeisalgia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedical Life Care Planners, LLC

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Supplement

    Dietary supplement

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

  • Placebo

    Dietary supplement

    Placebo

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: LiquidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood Alcohol Concentration

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.

Time frame
90 minutes
2

Alcohol Impairment

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.

Time frame
90 minutes

Secondary outcomes

1

Reduction of Hangover Symptoms

The secondary outcome measure is subjective reduction in veisalgia (hangover) symptoms using a standardized self-reported questionnaire the morning after excessive alcohol consumption in combination with BAC Down™ or placebo, utilizing The Acute Hangover Scale (AHS™), a 9-question survey where each symptom is rated on a scale for 0-7. Each subject will be provided with the AHS™ questionnaire via a text the morning following the three test dates. The text will be sent at the expected "awakening time" according to the subject to facilitate consistency and validity.

Time frame
12-24 hours after study completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical Life Care Planners, LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: