Nutritional Supplement for Hangover Symptoms

Overseen By Rachel Borch, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical Life Care Planners, LLC

Must not be taking: Antabuse, Opioids, Benzodiazepines, others

Disqualifiers: Alcohol use disorder, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nutritional supplement to determine if it can quickly lower blood alcohol levels and ease hangover symptoms after heavy drinking. Participants will receive either the supplement or a placebo to compare effects. The trial seeks individuals who regularly enjoy alcohol socially, have no history of alcohol abuse, and can handle drinking more than four drinks in one sitting. Those who meet these criteria and wish to explore a potential hangover remedy may find this trial a good fit. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potential hangover remedy.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, if you are using medications like Antabuse, certain antibiotics, nitrates, sulfonylureas, opioids, benzodiazepines, or antihistamines, you may not be eligible. It's best to discuss your current medications with the trial organizers to see if you qualify.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the nutritional supplement being tested for hangover symptoms contains ingredients like vitamins and minerals, which the FDA generally considers safe. However, reviews of hangover products indicate a lack of solid human research proving their safety or effectiveness specifically for hangover relief.

Some studies suggest that certain ingredients, like L-cysteine, might help reduce symptoms such as nausea, headache, stress, and anxiety. These findings, however, lack support from extensive human trials. More research is needed to fully understand the supplement's safety and effects for hangover relief. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this nutritional supplement for hangover symptoms because it offers a fresh approach compared to typical remedies like pain relievers and hydration drinks. Unlike standard treatments that focus on alleviating individual symptoms, this supplement is designed to address multiple hangover symptoms simultaneously. The supplement is unique because it uses a combination of vitamins, minerals, and natural compounds that may enhance the body's recovery processes after alcohol consumption. This multi-targeted approach has the potential to provide quicker and more comprehensive relief, making it a promising option for those seeking faster hangover recovery.

What evidence suggests that this nutritional supplement might be an effective treatment for hangover symptoms?

Research has shown that certain nutrients, such as nicotinic acid (a form of vitamin B3) and zinc, might help reduce hangover symptoms for social drinkers. One study found that individuals who took these nutrients reported less severe hangovers. However, many hangover products lack strong scientific evidence of effectiveness. Some research suggests that certain ingredients can alleviate symptoms like tiredness and thirst shortly after drinking. While there is some promise, scientists remain cautious about hangover supplements due to insufficient research on humans. Participants in this trial will receive either a nutritional supplement or a placebo to assess the supplement's effectiveness in reducing hangover symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Gregory L Smith, MD, MPH

Principal Investigator

NeX Therapeutics

Are You a Good Fit for This Trial?

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

No history of alcohol or substance abuse issues or alcohol-related medical conditions

No history of significant violent behavior

Not naïve to consuming more than 4 drinks at one time

Exclusion Criteria

I am currently taking medication that can interact badly with heavy drinking.

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume alcohol and receive either the nutraceutical or placebo, with BAC and impairment measurements taken

4 weeks

3 sessions (in-person)

Follow-up

Participants are monitored for hangover symptoms the morning after each session

12-24 hours after each session

What Are the Treatments Tested in This Trial?

Interventions

• Nutritional Supplement

Trial Overview 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.

How Is the Trial Designed?

Group I: Liquid Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Medical Life Care Planners, LLC

Lead Sponsor

Trials

5

Recruited

190+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6780234/

Dietary Nutrient Intake, Alcohol Metabolism, and Hangover ... This study suggests that social drinkers who have a higher dietary intake of nicotinic acid and zinc report significantly less severe hangovers.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0306460321002148

Unknown safety and efficacy of alcohol hangover ... A review of scientific literature revealed no peer-reviewed human data demonstrating either safety or efficacy of any of the 82 evaluated hangover products.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/20503245251355868

The alcohol hangover product market of the United States ... A 2019 study revealed more than 80 products available online with implied benefits to alcohol hangover. Since then, several developments may have influenced ...

4. nm.org nm.org/healthbeat/healthy-tips/do-hangover-pills-really-work

Do Hangover Pills Really Work? There are a lot of supplements on the market that claim to work as hangover pills. A hepatologist sorts fact from fiction.

5. mdpi.com mdpi.com/2072-6643/16/19/3262

Effects of GSH on Alcohol Metabolism and Hangover ... Among the nine items in the AHS results for females, the data showed that 'Hangover' and 'Tired' improved 1 h after alcohol consumption, and 'Thirst' improved 4 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34225031/

Unknown safety and efficacy of alcohol hangover ... A review of scientific literature revealed no peer-reviewed human data demonstrating either safety or efficacy of any of the 82 evaluated hangover products.

7. nature.com nature.com/articles/s41598-021-92676-0

The use of N-acetylcysteine in the prevention of hangover L-cysteine containing vitamin supplement which prevents or alleviates alcohol-related hangover symptoms: Nausea, Headache, stress and anxiety.