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Rapid BAC Reduction with Nutraceutical Blend Study

This study is testing a dietary supplement designed to quickly lower your blood alcohol concentration (BAC) and reduce alcohol impairment and hangover symptoms after drinking too much. Researchers want to see if this supplement works better than a placebo (an inactive substance) in reducing BAC and improving how you feel. To join, you must be over 21 and sign consent forms. The study will measure your BAC and how impaired you are at 90 minutes after taking the supplement or placebo. The study is currently recruiting 35 participants.

Study design
This is a double-blind, randomized, placebo-controlled study, meaning neither you nor the researchers will know if you're receiving the active supplement or placebo. It plans to enroll 35 participants.
What's involved
You would participate in two testing sessions, each lasting 4 hours, over a 2-week period. You will need to use Uber for transportation to and from each session.
Compensation
Not stated in the trial record.
Follow-up
Your blood alcohol concentration and alcohol impairment will be measured at 90 minutes after intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06722898

Rapid BAC Reduction with Nutraceutical Blend Study

Not Yet Recruiting
PHASE2Ages 21+InterventionalTreatment
Medical Life Care Planners, LLC
~35 participants
Updated 2024-12-09 on ClinicalTrials.gov
What's tested:SupplementPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Blood Alcohol Concentration
Measured over 90 minutes
+1 more outcome measured

Conditions

Alcohol Consumption
Alcohol
Hangover Symptoms, NAC
Veisalgia

Explore related trials

Alcohol Consumption

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Gregory L Smith, MD, MPH · PRINCIPAL_INVESTIGATOR · NeX Therapeutics

Who to contact

Gregory L Smith, MD, MPH
[email protected]
4044514045
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Blood Alcohol Concentration90 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 Impairment90 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.