Trials Sponsors Conditions Drugs Pricing

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
+6 more secondary outcomes

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
+1 more other outcomes

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-CPDietary 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

PlaceboDietary supplement

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

Placebo

Eligibility Criteria

Age21 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

English-literate, non-smoking (\> 6 months),
Men and women aged 25 to 45 years,

Sponsors & Collaborators

Quantum Biopharma
Industrylead

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33634, United States

MeSH Terms

Conditions

Alcoholic Intoxication

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

Eric Sikorski, PhD
Applied Science and Performance Institute
PRINCIPAL INVESTIGATOR

Enrollment

26 participants (actual enrollment reported by the registry).

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

Actual (reported)

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,
+12 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (11)

Other Outcomes (4)

Study Arms (2)

FSD-F2R6-A-CP

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (11)

Other Outcomes (4)

Study Arms (2)

FSD-F2R6-A-CP

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations