Nutritional Supplement for Hangover Symptoms

Recruiting in Palo Alto (17 mi)

Overseen ByGregory L Smith, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Medical Life Care Planners, LLC

Prior Safety Data

Trial Summary

What is the purpose of 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 \&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.

Eligibility Criteria

This trial is for individuals who frequently consume alcohol and experience hangovers. Participants must be healthy, within a specific age range, and not pregnant. They should have no history of alcoholism or liver disease, and agree to follow the study's protocol including Uber transportation after sessions.

Inclusion Criteria

I have never had liver disease.

I am over 21 years old.

I am not on any of the listed medications.

Exclusion Criteria

I am not taking Antabuse, Beta-lactam antibiotics, Nitrates, Sulfonylureas, Pyrazoles, or isobutyramide regularly.

I am currently using substances like THC, Kava, Kratom, or psilocybin.

I do not have conditions like liver disease, diabetes, epilepsy, high blood pressure, heart issues, MS, schizophrenia, TBI, stomach ulcers, or opioid addiction.

Participant Groups

The study tests a nutritional supplement against a placebo to see if it can quickly lower blood alcohol levels and reduce impairment/hangover symptoms after drinking. It involves controlled drinking sessions with measurements taken at various intervals using breathalyzers and an app.

2Treatment groups

Active Control

Placebo Group

Group I: LiquidActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention