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

NCT06505239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

  • Acute Alcohol Intoxication

Interventions

DIETARY_SUPPLEMENT

FSD-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_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Quantum Biopharma

    lead INDUSTRY

Principal Investigators

  • Eric Sikorski, PhD · Applied Science and Performance Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2024-11-07
Completion
2024-11-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505239 on ClinicalTrials.gov