Rapid BAC Reduction with Nutraceutical Blend Study

Launched by MEDICAL LIFE CARE PLANNERS, LLC · Dec 3, 2024

Keywords

ClinConnect Summary

The "Rapid BAC Reduction with Nutraceutical Blend Study" is a clinical trial designed to test a nutritional supplement aimed at quickly reducing blood alcohol concentration (BAC) and the effects of hangovers after drinking too much alcohol. This study will involve 35 participants who are regular social drinkers and over the age of 21. Eligible individuals must sign consent forms, own a smartphone, and not have any history of alcohol or substance abuse, liver disease, or certain medical conditions. Participants will be monitored for safety and will have to attend three testing sessions over two weeks, where they will consume a controlled amount of alcohol and receive either the active supplement or a placebo (a non-active version).

During the study, participants' BAC levels and cognitive or physical impairment will be measured at various times after drinking. The trial will also assess hangover symptoms the next morning through text messages. All participants will have transportation provided through Uber to ensure they can safely return home. This research aims to provide valuable information about how well the supplement can help reduce the effects of alcohol, potentially offering a new way to manage alcohol-related issues after a night of drinking.

Gender

ALL

Eligibility criteria

• 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