Clinical trial NCT06505239: Assessing the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication
Official title: A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication (METAL-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Alcohol Intoxication
Lead sponsor: Quantum Biopharma
Sponsor class: INDUSTRY
First posted: 2024-07-17
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This will be a (2 visit) double-blind, randomized, placebo crossover design clinical study to assess the potential benefits of FSD-F2R6-A-CP versus a placebo by assessing its impact on side effect profiles as well as cognitive abilities, motor abilities, and breath alcohol concentration following ingestion of alcohol followed by the dietary supplement or placebo. This study will enroll healthy men and women.


Eligibility criteria: Inclusion Criteria:

* English-literate, non-smoking (\> 6 months),
* Men and women aged 25 to 45 years,
* Body mass index (BMI) of 18.5 to 32.0 kg/m2, and weighing between 110 and 220 lbs (50-100 kg).
* Free of the diseases listed in exclusion criteria according to their medical history,
* 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.
* Capable of consuming 4-6 standard drinks for women or 5-7 standard drinks for men on a single occasion without experiencing moderate sedation, vomiting, or aggression, to be eligible for the study. Moderate sedation is defined as the subject must be able to communicate and follow simple directions following the consumption of indicated number of drinks.
* Agree not to get tattoos or body piercings, or receive vaccines during the study period, or 7 days prior to the study period.
* Female subjects who must test negative on a urine pregnancy test, and cannot be pregnant or lactating. All subjects are required to either refrain from sex or use at least one form of contraception throughout the study, including a condom or either an oral or intrauterine contraceptive.
* Men who must agree not to donate sperm for 90 days following the trial.
* Experienced at least 2 hangovers
* Clinical laboratory values within the most recent acceptable laboratory test range, and/or values are deemed by the Investigator /Sub-Investigator as "Not Clinically Significant" as per CBC/CMP, urinalysis, and coagulation testing.

Exclusion Criteria:

* A known history or presence of any clinically relevant conditions affecting the liver, kidneys, gastrointestinal system, cardiovascular system, cerebrovascular system, lungs, endocrine system, immune system, musculoskeletal system, nervous system, psychiatric state, respiratory system, skin, or blood, unless deemed not clinically significant by the Investigator/Sub-Investigator. This includes a significant history or current issues with gastrointestinal pathology, such as chronic diarrhea or inflammatory bowel diseases, or conditions affecting drug absorption, distribution, metabolism, or excretion
* 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 are also excluded
* Are on a ketogenic or very low carbohydrate diet within the past 30 days.
* Significant physical or organ abnormalities, a positive screening for a HIV, Hepatitis B or C (as determined by medical health questionnaires), or positive test result for drugs with abuse potential (cannabis, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines)
* Alcohol-naïve
* Positive pregnancy test
* A history of significant alcohol sensitivity
* A history of adverse reactions to power (energy) drinks or caffeine,
* Severe food allergies, or dietary restrictions.
* Allergic reactions to any ingredients in the FSD-F2R6-A-CP and placebo.
* A psychiatric history of certain disorders, a first-degree relative with specific psychiatric or alcohol use disorders,
* An intolerance to blood sampling, recent blood or plasma donations within the past 60 days.
* Recently used enzyme-modifying drugs within the previous 30 days including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John's Wort, and rifampicin).
* Current or past history within the last 2 years of alcohol or drug dependence (excluding caffeine and nicotine).
* Current or past history within the last 5 years of major depressive disorder, obsessive-compulsive disorder, panic disorder, anorexia nervosa, or bulimia nervosa. First-degree relative with current or historical Alcohol Use Disorder (AUD).
* Intolerance to and/or difficulty with blood sampling through venipuncture or indwelling catheter.
* Used of prescription medication (other than contraception or occasional paracetamol) or over-the-counter medications including supplements within 14 days prior to session 1,
* A positive alcohol test at check-in on treatment day,
* Recent tattoos or piercings (within 7 days of study enrollment)
* Any condition deemed by the Investigator or Sponsor to interfere with study participation will be excluded.

Primary outcomes:
measure: Intoxication
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Impairment
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Mental Fatigue
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and4 hours post-treatment
measure: Clearheaded-Muzzy
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Clumsy-Well Coordinated
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Energetic-Lethargic
timeFrame: Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment
measure: Drowsy-Alert
timeFrame: Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment
measure: Mentally Slow-Quick Witted
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Headache
timeFrame: Change in pre-treatment score to 0.5, 1, 2, 4 and 8 hours post-treatment
Secondary outcomes:
measure: Druid App Test
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Digital Symbol Substitution Task (DSST)
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Trail Making Test (TMT)
timeFrame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
measure: Breath Alcohol Concentration
timeFrame: Change in pre-treatment score to 0.5, 1, 1.5, 2, 3 and 4 hours post-treatment
measure: Acute Hangover Severity Scale (AHSS)
timeFrame: Measured at 8 and 24 hours after treatment
measure: Single Item Hangover Severity Score
timeFrame: Measured at 8 and 24 hours after treatment
measure: Systolic blood pressure
timeFrame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
measure: Diastolic blood pressure
timeFrame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
measure: Heart rate
timeFrame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
measure: Respiratory rate
timeFrame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
measure: Temperature
timeFrame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Other outcomes:
measure: Adverse Events (AEs)
timeFrame: Pre-treatment until 24 hour post-treatment visit
measure: Complete blood count (CBC)
timeFrame: Change in test results from baseline to 24 hours post-treatment
measure: Comprehensive metabolic blood panel (CMP)
timeFrame: Change in test results from baseline to 24 hours post-treatment
measure: Blood coagulation
timeFrame: Change in test results from baseline to 24 hours post-treatment
Locations:
city: Tampa
country: United States
facility: Applied Science and Performance Institute
state: Florida
Study officials:
affiliation: Applied Science and Performance Institute
name: Eric Sikorski, PhD
role: PRINCIPAL_INVESTIGATOR
References: