Assessing the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication
NCT Number: NCT06505239
Acronym: METAL-2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Alcohol Intoxication
Interventions: DIETARY_SUPPLEMENT: FSD-F2R6-A-CP|DIETARY_SUPPLEMENT: Placebo
Sponsor: FSD Pharma, Inc.
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2024-09
Locations: Applied Science and Performance Institute, Tampa, Florida, 33634, United States

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.

Primary Outcome Measures: 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, 4, 6 and 8 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, 4, 6 and 8 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, 4, 6 and 8 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, 4, 6 and 8 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, 4, 6 and 8 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, 4, 6 and 8 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, 4, 6 and 8 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, 4, 6 and 8 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, 6 and 8 hours post-treatment
Secondary Outcome Measures: Druid App Test, This is a peer-reviewed, phone app with 4 different tests that test for cognitive and motor impairments., Change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Digital Symbol Substitution Task (DSST), 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., Change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Trail Making Test (TMT), 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., Change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Breath Alcohol Concentration, To quantify the participants' level of intoxication through objective measures, breath alcohol concentrations will be measured with a breathalyzer., Change in pre-treatment score to 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Acute Hangover Severity Scale (AHSS), This is a 12-item questionnaire that rates the severity of a hangover from 0 to 120 with higher scores indicating worse hangover symptoms., Measured at 6, 8, and 24 hours after treatment|Single Item Hangover Severity Score, 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., Measured at 6, 8, and 24 hours after treatment|Systolic blood pressure, Systolic blood pressure measured in mmHg., Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Diastolic blood pressure, Diastolic blood pressure measured in mmHg, Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Heart rate, Heart rate measured in beats per minute, Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Respiratory rate, Respiratory rate measured in respirations per minute, Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2, 4, 6 and 8 hours post-treatment|Temperature, Temperature measured in degrees fahrenheit with an infrared thermometer, Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2, 4, 6 and 8 hours post-treatment
Other Outcome Measures: Adverse Events (AEs), Incidence of AEs will be determined based on observation and verbal subject questioning., Pre-treatment until 24 hour post-treatment visit|Complete blood count (CBC), Safety blood test measured by a laboratory using a reference range, Change in test results from baseline to 24 hours post-treatment|Comprehensive metabolic blood panel (CMP), Safety blood test measured by a laboratory using a reference range, Change in test results from baseline to 24 hours post-treatment|Blood coagulation, Safety blood test measured by a laboratory using a reference range, Change in test results from baseline to 24 hours post-treatment