Assessing the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication

NCT06505239 | Completed

• 1 other identifier: FSD-F2R6-002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Alcohol Intoxication

Outcome Measures

Primary Outcomes (9)

• Intoxication

  Intoxication will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of intoxication.

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Impairment

  Impairment will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of impairment.

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Mental Fatigue

  Mental fatigue will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of mental fatigue.

  Change in pre-treatment score to 0.5, 1, 2 and4 hours post-treatment

• Clearheaded-Muzzy

  Clearheaded-Muzzy will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Clumsy-Well Coordinated

  Clumsy-Well Coordinated will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Energetic-Lethargic

  Energetic-Lethargic will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.

  Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment

• Drowsy-Alert

  Drowsy-Alert will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.

  Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment

• Mentally Slow-Quick Witted

  Mentally Slow-Quick Witted will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Headache

  Headache will be measured on a 100 mm VAS. The subject will indicate the severity of any headache by drawing a vertical line on the horizontally positioned VAS. The left end (0 mm) of the VAS will designate 'no pain' and the right end (100mm) will designate 'most severe pain imaginable' with no intermediate divisions or descriptive terms.

  Change in pre-treatment score to 0.5, 1, 2, 4 and 8 hours post-treatment

Secondary Outcomes (11)

• Druid App Test

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Digital Symbol Substitution Task (DSST)

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Trail Making Test (TMT)

  Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment

• Breath Alcohol Concentration

  Change in pre-treatment score to 0.5, 1, 1.5, 2, 3 and 4 hours post-treatment

• Acute Hangover Severity Scale (AHSS)

  Measured at 8 and 24 hours after treatment

Other Outcomes (4)

• Adverse Events (AEs)

  Pre-treatment until 24 hour post-treatment visit

• Complete blood count (CBC)

  Change in test results from baseline to 24 hours post-treatment

• Comprehensive metabolic blood panel (CMP)

  Change in test results from baseline to 24 hours post-treatment

Study Arms (2)

FSD-F2R6-A-CP

ACTIVE COMPARATOR

Dietary Supplement: FSD-F2R6-A-CP

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

FSD-F2R6-A-CP DIETARY_SUPPLEMENT

FSD-F2R6-A-CP is a unique dietary supplement with natural ingredients, vitamins and minerals that potentially enhances cognition, replenishes cofactors needed for alcohol metabolism and may accelerate alcohol metabolism in the body.

FSD-F2R6-A-CP

Placebo DIETARY_SUPPLEMENT

Placebo drink designed to match FSD-F2R6-A-CP in color and taste.

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Quantum Biopharma: lead

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33634, United States

Location

MeSH Terms

Conditions

Alcoholic Intoxication

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Eric Sikorski, PhD

  Applied Science and Performance Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 17, 2024
• Study Start: July 12, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)