Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616859
Status:
UNKNOWN
Last Update Posted:
2020-11-09
First Post:
2020-10-30
Brief Title:
Binge Drinking of Alcohol Mixed With Energy Drinks
Sponsor:
Fundació Institut Germans Trias i Pujol
Organization:
Fundació Institut Germans Trias i Pujol
Study Overview
Official Title:
Combination of Alcohol and Energy Drinks in a Binge Drinking Pattern Acute Effects and Gender Differences
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENERGYBINGE
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 11 and four treatment conditions will be administered alcoholED alcoholplacebo of ED placebo of alcoholED and placebo of alcoholplacebo 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
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 11 and four treatment conditions will be administered alcoholED alcoholplacebo of ED placebo of alcoholED and placebo of alcoholplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUGTPENERGYBINGEPNSD1 | OTHER | Hospital Universitari Germans Trias i Pujol | None |