NCT06505239

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Quantum Biopharma · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-12
• Primary completion: 2024-11-07
• Completion: 2024-11-07
• First posted: 2024-07-17
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States