Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT04616859
Brief Summary:
The purpose of the study is to assess the relevance of gender in the acute effects (subjective, physiological and driving-related skills) observed after controlled administration of alcohol in a binge-drinking pattern mixed with energy drinks (AmED)
Detailed Description:
Consumption of alcohol mixed with energy drinks (AmED) has increased mainly among young people. Energy drinks (ED) are usually combined with alcohol with the intention of counteracting its effects. However, most studies have not shown a reduction in drunkenness and consumption is related with engagement of risk-taking behaviours like driving under alcohol effects. It is already known that alcohol concentrations and effects are higher in women than in men even after adjusting dose by weight.
The relevance of gender in the acute effects of alcohol associated with ED consumed in a binge-drinking pattern has been poorly studied. A randomized clinical trial will be conducted in healthy volunteers (1:1) and four treatment conditions will be administered: alcohol+ED, alcohol+placebo of ED, placebo of alcohol+ED and placebo of alcohol+placebo of ED. Subjective and physiological effects, driving related skills, and alcohol and caffeine concentrations will be measured along an 8-hours period. A pilot study has been conducted with the first 6 volunteers to select the alcohol doses. In the definitive study 70 g of alcohol in men and 55 g in women will be used.
Study:
NCT04616859
Study Brief:
Protocol Section:
NCT04616859