An interventional study of FSD-F2R6-A-CP and Placebo in Acute Alcohol Intoxication, sponsored by Quantum Biopharma. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Quantum Biopharma · Not applicable, Interventional, and Treatment
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.
76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.
This study's enrollment of 26 is below the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.
Browse Alcoholic Intoxication studies →Quantum Biopharma is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: FSD-F2R6-A-CP
Dietary Supplement: Placebo
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.
Placebo drink designed to match FSD-F2R6-A-CP in color and taste.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change in pre-treatment score to 0.5, 1, 2, 4 and 8 hours post-treatment
Druid App Test
This is a peer-reviewed, phone app with 4 different tests that test for cognitive and motor impairments.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
This is a 12-item questionnaire that rates the severity of a hangover from 0 to 120 with higher scores indicating worse hangover symptoms.
Time frame: 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.
Time frame: Measured at 8 and 24 hours after treatment
Systolic blood pressure
Systolic blood pressure measured in mmHg.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Adverse Events (AEs)
Incidence of AEs will be determined based on observation and verbal subject questioning.
Time frame: Pre-treatment until 24 hour post-treatment visit
Complete blood count (CBC)
Safety blood test measured by a laboratory using a reference range
Time frame: 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
Time frame: Change in test results from baseline to 24 hours post-treatment
Blood coagulation
Safety blood test measured by a laboratory using a reference range
Time frame: Change in test results from baseline to 24 hours post-treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Nov 2024, 3 months.
Of 29 interventional studies with no phase under Alcoholic Intoxication, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 58. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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