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| Name | Class |
|---|---|
| Germans Trias i Pujol Hospital | OTHER |
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The purposes of this study are 1) to determine the pharmacokinetics of alcohol after experimental administration of alcohol simulating a "binge-drinking" episode in young adults 2) to determine the profile of biomarkers of acute damage and exposure/consumption to alcohol 3) to determine the pharmacokinetic parameters and evaluate the acute effects alcohol and its relationship with biomarkers.
Binge drinking (BD) has become trendy among adolescents and young adults. It is defined as a pattern of drinking that reach blood alcohol concentration (BAC) to 80 mg/dl in a short period of time (2 hours), that typically occurs after 4 drinks for women and 5 drinks for men. Despite its high prevalence and association with morbidity and mortality, there are no previous experimental studies evaluating alcohol concentrations after a "binge drinking" episode neither its effects on biomarkers of acute damage and exposure/consumption.
The aims of this study are 1) to determine the pharmacokinetics of alcohol after experimental administration of alcohol simulating a "binge-drinking" episode in young adults 2) to determine the profile of biomarkers of acute damage and exposure/consumption to alcohol 3) to determine the pharmacokinetic parameters and evaluate the acute effects alcohol and its relationship with biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 70 grams alcohol | Experimental | Males and Females: Alcohol 70 grams (220 ml Vodka Absolut®), single dose, oral administration - 70 grams of alcohol mixed with zero orange soda without bubbles distributed in 6 glasses (total volume 900 ml) over a 2-hour period (20 minutes for glass) |
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| 100 grams alcohol | Experimental | Males: Alcohol 100 grams (312 ml Vodka Absolut®), single dose, oral administration - 100 grams of alcohol mixed with zero orange soda without bubbles distributed in 6 glasses (total volume 900 ml) over a 2-hour period (20 minutes for glass) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Other | Administration of one dose of alcohol among two possible different doses (in males) or only one possible dose (in females) simulating a binge drinking episode under experimental conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC 0-24h) of alcohol concentration in blood. | Calculation of AUC of the concentrations of alcohol in blood. | From pre-dose (baseline, 0 hours) to 0.33 hours (h), 0.66 h, 1.33 h, 1.66 h, 2 h, 2.33 h, 2.66 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h and 24 h post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC 0-24h) of biomarkers of acute damage and exposure/consumption in blood. | Calculation of AUC of the concentrations of other biomarkers of exposure/consumption in blood. | From pre-dose (base-line, 0 hour), to 2.33 hour (h), 4 h, 6 h, 8 h, 24 h post-dose. Additional samples will be collected at 7,14 and 21 days post-administration |
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Inclusion Criteria:
Exclusion Criteria:
Daily consumption >5 coffees, tea, cola refreshment or other stimulating drinks or containing xanthines in the three months prior to the study start.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angels Fortes, BS | Contact | 34 93 497 89 56 | ceic.germanstrias@gencat.cat |
| Name | Affiliation | Role |
|---|---|---|
| Esther Papaseit, MD, PhD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (HUGTP-IGTP) | Recruiting | Badalona | Barcelona | 08916 | Spain |
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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Two groups (one receiving 70 g and other receiving 100 g)
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Simple Blind
| Cumulative amount of biomarkers of exposure/consumption excreted into urine up to collection time of last measurable concentration. | Urine will be collected in intervals and the total amount of biomarkers of exposure/consumption will be calculated (ethylglucuronide and ethylsulfate) | From pre-dose (base-line, 0 hours (h)) and following intervals 0-2h, 2-4h, 4-6h, 6-8h, 8-10h, 10-12h and 12-24h to 24h post-administration |
| Elimination half-life f the concentrations of alcohol in blood. | Calculation of elimination half-life of the concentrations of alcohol in blood. | From pre-dose (baseline, 0 hours) to 0.33 h, 0.66 h, 1.33 h, 1.66 h, 2 h, 2.33 h, 2.66 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h and 24 h post-dose |
| Area Under the Concentration-Time Curve (AUC 0-24h) of alcohol in breath (BrAC) | Calculation of AUC of the concentrations of alcohol in breath (BrAC) | From pre-dose (baseline, 0 hours) to 0.33 h, 0.66 h, 1.33 h, 1.66 h, 2 h, 2.33 h, 2.66 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h and 24 h post-dose |
| Change in blood pressure | Blood pressure measured in mmHg | From pre-dose (baseline, 0 hours) to 24 hours post-dose |
| Change in heart rate | Heart rate measured in beats per minute | From pre-dose (baseline, 0 hours) to 24 hours post-dose |
| Change in oral temperature | Oral temperature measured in Celsius degrees | From pre-dose (baseline, 0 hours) to 24 hours post-dose |
| Change in drunkenness | Drunkenness will be measured using rate scales | From pre-dose (baseline, 0 hours) to 24 hours post-dose. |
| Change in subjective effects | Subjective effects will be measured using rate scales | From pre-dose (baseline, 0 hours) to 24 hours post-dose. |
| Number of Participants with Serious and Non-Serious Adverse Events | Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators. | From pre-dose (baseline, 0 hours) to 21 days post-dose. |
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| D001519 | Behavior |
| D001523 | Mental Disorders |