Rapid BAC Reduction with Nutraceutical Blend Study

NCT06722898 | Not Yet Recruiting Phase 2

• 1 other identifier: 000011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

alcohol; blood alcohol; alcohol intoxication; alcohol impairment; BAC; BAC reduction; alcohol half-life; blood alcohol concentration; veisalgia; hangover

Outcome Measures

Primary Outcomes (2)

• 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.

  90 minutes

• 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.

  90 minutes

Secondary Outcomes (1)

• Reduction of Hangover Symptoms

  12-24 hours after study completion

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Liquid

ACTIVE COMPARATOR

Dietary Supplement: Supplement

Interventions

Supplement DIETARY_SUPPLEMENT

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

Liquid

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Life Care Planners, LLC: lead

Study Sites (1)

The Warehouse St. Pete

St. Petersburg, Florida, 33712, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcoholic Intoxication

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Gregory L Smith, MD, MPH

  NeX Therapeutics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory L Smith, MD, MPH

CONTACT

4044514045; disabilityevaluators@gmail.com

Rachel Borch, BA

CONTACT

2077017091; rae@nex-therapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 7, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year

Locations

US (1)