FSD-F2R6-A-CP for Alcohol Intoxication (METAL-2 Trial)

N/A

Recruiting

Led By Eric Sikorski, PhD

Research Sponsored by Quantum Biopharma

Eligibility Criteria Checklist

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

Must have

An ECG value of ≤ 440 msec for males and ≤ 460 msec for females, as measured by an FDA-cleared ECG device (6-lead device, KardiaMobile), administered by the investigator

Men and women aged 25 to 45 years

Must not have

Major surgery within the past 6 months, a history of seizures, significant head trauma, or neurosurgery, or any clinically significant illness within 30 days prior to dosing

Recently used enzyme-modifying drugs within the previous 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment

Summary

"This trial will test a new supplement compared to a placebo in a double-blind study with two visits. The study will look at how the supplement affects side effects, cognitive abilities, motor abilities, and breath

Who is the study for?

This trial is for English-literate, non-smoking adults aged 25 to 45 with a BMI of 18.5-32 and weight between 110-220 lbs. It's designed for those who are generally healthy and free from the diseases listed in the exclusion criteria.

What is being tested?

The study tests FSD-F2R6-A-CP against a placebo in managing side effects of alcohol intoxication. Participants will visit twice, receive both treatments at different times (crossover), and be assessed on cognitive, motor skills, and breath alcohol levels.

What are the potential side effects?

Specific side effects aren't detailed here but typically could include digestive issues, dizziness or headaches related to the intervention or alcohol consumption itself.

Eligibility Criteria

Inclusion Criteria

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

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My heart's electrical activity, measured by ECG, is within the normal range.

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I am between 25 and 45 years old.

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My BMI is between 18.5 and 32, and I weigh between 110 and 220 lbs.

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I can drink 4-7 alcoholic drinks without feeling overly sedated, sick, or aggressive.

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I am not pregnant or breastfeeding, and my pregnancy test was negative.

Exclusion Criteria

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

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I haven't had major surgery, significant head injuries, seizures, or serious illnesses in the last 6 months.

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I have not taken any enzyme-modifying drugs in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment for reporting.