Acute Alcohol Intoxication
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFSD-F2R6-A-CP
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.
DIETARY_SUPPLEMENTPlacebo
Placebo drink designed to match FSD-F2R6-A-CP in color and taste.
Sponsors
Quantum Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mentally Slow-Quick Witted | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | 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. |
| Energetic-Lethargic | Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment | 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. |
| Drowsy-Alert | Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment | 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. |
| Headache | Change in pre-treatment score to 0.5, 1, 2, 4 and 8 hours post-treatment | 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. |
| Intoxication | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | 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. |
| Impairment | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | 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. |
| Mental Fatigue | Change in pre-treatment score to 0.5, 1, 2 and4 hours post-treatment | 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. |
| Clearheaded-Muzzy | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | 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. |
| Clumsy-Well Coordinated | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment | Respiratory rate measured in respirations per minute |
| Temperature | Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment | Temperature measured in degrees fahrenheit with an infrared thermometer |
| Heart rate | Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment | Heart rate measured in beats per minute |
| Druid App Test | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | This is a peer-reviewed, phone app with 4 different tests that test for cognitive and motor impairments. |
| Digital Symbol Substitution Task (DSST) | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | This is a computerized test that will be used to assess the subject's cognitive functioning. This will test processing speed, working memory, visuospatial processing and attention. |
| Trail Making Test (TMT) | Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment | This is a neuropsychological test of visual attention and task switching. Subjects will connect a set of 25 dots in order as quickly and accurately as possible. This will provide visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. This test will be completed on a computer. |
| Breath Alcohol Concentration | Change in pre-treatment score to 0.5, 1, 1.5, 2, 3 and 4 hours post-treatment | To quantify the participants' level of intoxication through objective measures, breath alcohol concentrations will be measured with a breathalyzer. |
| Acute Hangover Severity Scale (AHSS) | Measured at 8 and 24 hours after treatment | This is a 12-item questionnaire that rates the severity of a hangover from 0 to 120 with higher scores indicating worse hangover symptoms. |
| Single Item Hangover Severity Score | Measured at 8 and 24 hours after treatment | This is a single item outcome measure that rates the severity of a hangover from 0 to 10 with higher scores indicating worse hangover symptoms. |
| Systolic blood pressure | Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment | Systolic blood pressure measured in mmHg. |
| Diastolic blood pressure | Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment | Diastolic blood pressure measured in mmHg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Pre-treatment until 24 hour post-treatment visit | Incidence of AEs will be determined based on observation and verbal subject questioning. |
| Blood coagulation | Change in test results from baseline to 24 hours post-treatment | Safety blood test measured by a laboratory using a reference range |
| Comprehensive metabolic blood panel (CMP) | Change in test results from baseline to 24 hours post-treatment | Safety blood test measured by a laboratory using a reference range |
| Complete blood count (CBC) | Change in test results from baseline to 24 hours post-treatment | Safety blood test measured by a laboratory using a reference range |
Countries
United States
Outcome results
None listed