What is the mechanism of action of this treatment?

Common treatments for alcohol consumption often involve dietary supplements that aim to alter the metabolism or absorption of alcohol. These supplements may contain ingredients that enhance the activity of enzymes like alcohol dehydrogenase and aldehyde dehydrogenase, which are responsible for breaking down alcohol in the liver. By accelerating the metabolic process, these supplements can reduce blood and breath alcohol levels more quickly, potentially minimizing the intoxicating effects and reducing the risk of alcohol-related harm. This is particularly important for patients as it can help manage acute alcohol intoxication and support long-term strategies for reducing alcohol consumption.

What side effects are associated with this type of intervention?

Common treatments for alcohol use disorder (AUD) include medications such as disulfiram, naltrexone, acamprosate, and gabapentin. Disulfiram can cause side effects like drowsiness, headache, and a metallic or garlic-like taste in the mouth. Naltrexone may lead to nausea, headache, dizziness, and fatigue. Acamprosate's side effects include diarrhea, anxiety, and insomnia. Gabapentin can cause dizziness, fatigue, and peripheral edema. While specific dietary supplements aimed at altering alcohol metabolism or absorption are less commonly used, they may carry risks such as gastrointestinal discomfort or interactions with other medications. Patients should consult their healthcare provider to determine the most appropriate treatment and manage potential side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcohol dependence, including acamprosate and naltrexone. These medications work by different mechanisms to reduce cravings and prevent relapse. Acamprosate helps to stabilize chemical signaling in the brain that is disrupted by alcohol dependence, while naltrexone blocks opioid receptors involved in the rewarding effects of alcohol. Although the study on a blend of dietary supplements altering metabolism or absorption of alcohol is not directly mentioned as FDA-approved, it represents a novel approach that could complement existing treatments by potentially reducing blood and breath alcohol levels.

What other types of research exist?

Promising alternatives for alcohol consumption patients include: 1) Medications like naltrexone and acamprosate, which help reduce alcohol cravings and dependence. 2) Behavioral therapies such as cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET) that address the psychological aspects of alcohol use. 3) Nutritional interventions, including the use of specific vitamins and minerals to support liver health and reduce alcohol-related damage. 4) Emerging research on the use of probiotics and gut microbiota modulation to influence alcohol metabolism and reduce its harmful effects.

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Safety Shot for Alcohol Consumption Effects

N/A

Waitlist Available

Research Sponsored by The Center for Applied Health Sciences, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight of at least 110 pounds

Age between the ages of 21 and 55 (inclusive)

Must not have

History of hyperparathyroidism or an untreated thyroid disease

History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

Summary

This trial tests a mix of vitamins and minerals to see if they affect alcohol levels in healthy men and women. Participants will drink alcohol with either the supplement or a non-active substance. The study will measure alcohol levels in their breath and blood, as well as how they feel afterward.

Who is the study for?

This trial is for healthy men and women aged 21-55, with normal blood pressure, heart rate, BMI of 18.5-34.9, and weight over 110 pounds. Participants must not have diabetes, certain cancers within the last five years or be pregnant/nursing; they should also avoid alcohol/caffeine before trials and agree to transport home after.

What is being tested?

The study tests a dietary supplement's effect on alcohol levels in the body compared to a placebo. It involves 36 participants who will randomly receive either the supplement or placebo in a controlled environment to see if it alters blood and breath alcohol concentrations.

What are the potential side effects?

Potential side effects are not specified but may include reactions related to ingredients in the dietary supplement or due to interaction with alcohol consumption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 110 pounds.

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I am between 21 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had hyperparathyroidism or untreated thyroid disease.

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I haven't had cancer in the last 5 years, except for non-melanoma skin cancer.

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I have a history of major gut surgery or disorders affecting food absorption.

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I have a chronic inflammatory condition like rheumatoid arthritis or Crohn's.

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I am currently smoking or quit smoking within the last month.

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I have diabetes or another hormone-related condition.

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I have no recent heart, lung, liver, or kidney diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concentration

Energy

Fatigue

+4 more

Secondary study objectives

Blood acetaldehyde level

Blood alcohol dehydrogenase level

Blood alcohol level

+3 more

Other study objectives

Diastolic blood pressure

Heart rate

Systolic blood pressure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Safety ShotExperimental Treatment1 Intervention

12 oz of Safety Shot containing a blend of vitamins, minerals and botanical extracts.

Group II: PlaceboPlacebo Group1 Intervention

12 oz of flavor-matched water.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Safety Shot

2023

N/A

~40

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcohol consumption often involve dietary supplements that aim to alter the metabolism or absorption of alcohol. These supplements may contain ingredients that enhance the activity of enzymes like alcohol dehydrogenase and aldehyde dehydrogenase, which are responsible for breaking down alcohol in the liver. By accelerating the metabolic process, these supplements can reduce blood and breath alcohol levels more quickly, potentially minimizing the intoxicating effects and reducing the risk of alcohol-related harm. This is particularly important for patients as it can help manage acute alcohol intoxication and support long-term strategies for reducing alcohol consumption.

Validation of serotonin transporter mRNA as a quantitative biomarker of heavy drinking and its comparison to ethyl glucuronide/ethyl sulfate: A randomized, double-blind, crossover trial.[How valid are self-reported intakes of beer, wine and spirits in population studies?].