Acute Alcohol IntoxicationMETAL-2NCT06505239
Assessing the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication
A study testing FSD-F2R6-A-CP in people with Acute Alcohol Intoxication, run by Quantum Biopharma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Alcohol Intoxication
- What is being tested?
- FSD-F2R6-A-CP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to 7 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science and Performance Institute
Tampa, Florida, 33634
About this study
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)
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
- Being tested
- FSD-F2R6-A-CP, Placebo
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
Placebo drink designed to match FSD-F2R6-A-CP in color and taste.
| Study group | Role | What they receive |
|---|---|---|
| FSD-F2R6-A-CP | Active comparator | Not described Receives: Dietary Supplement: FSD-F2R6-A-CP |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in pre-treatment score to 0.5, 1, 2, 4 and 8 hours post-treatment
Secondary outcomes (11)
Druid App Test
This is a peer-reviewed, phone app with 4 different tests that test for cognitive and motor impairments.
Measured: Change in pre-treatment score to 0.5, 1, 2 and 4 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.
Measured: Change in pre-treatment score to 0.5, 1, 2 and 4 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.
Measured: Change in pre-treatment score to 0.5, 1, 2 and 4 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.
Measured: Change in pre-treatment score to 0.5, 1, 1.5, 2, 3 and 4 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: Measured at 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: Measured at 8 and 24 hours after treatment
Systolic blood pressure
Systolic blood pressure measured in mmHg.
Measured: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Diastolic blood pressure
Diastolic blood pressure measured in mmHg
Measured: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Heart rate
Heart rate measured in beats per minute
Measured: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Respiratory rate
Respiratory rate measured in respirations per minute
Measured: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Temperature
Temperature measured in degrees fahrenheit with an infrared thermometer
Measured: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start12 Jul 2024
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Alcohol IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sikorski, PhD, Principal investigator, Applied Science and Performance Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505239
- Sponsor's protocol ID
- FSD-F2R6-002
- Acronym
- METAL-2
- Status last verified
- May 2025
- First submitted
- 3 Jul 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06505239
- Acronym / sponsor ID
- METAL-2 / FSD-F2R6-002
- Conditions
- Acute Alcohol Intoxication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Quantum BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSD-F2R6-A-CP | Active comparator | Dietary Supplement: FSD-F2R6-A-CP |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSD-F2R6-A-CPFSD-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 supplement | FSD-F2R6-A-CP |
| PlaceboPlacebo drink designed to match FSD-F2R6-A-CP in color and taste. | Dietary supplement | Placebo |
Primary outcome
Intoxication
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Energetic-Lethargic
Time frame: 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
Time frame: 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.
Mentally Slow-Quick Witted
Time frame: 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.
Headache
Time frame: 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.
11 secondary outcomes
Druid App Test
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Digital Symbol Substitution Task (DSST)
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Trail Making Test (TMT)
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Breath Alcohol Concentration
Time frame: Change in pre-treatment score to 0.5, 1, 1.5, 2, 3 and 4 hours post-treatment
Acute Hangover Severity Scale (AHSS)
Time frame: Measured at 8 and 24 hours after treatment
Single Item Hangover Severity Score
Time frame: Measured at 8 and 24 hours after treatment
Systolic blood pressure
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Diastolic blood pressure
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Heart rate
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Respiratory rate
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Temperature
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sikorski, PhD principal investigator
Applied Science and Performance Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FSD-F2R6-A-CP in people with Acute Alcohol Intoxication, run by Quantum Biopharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intoxication (time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.