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Biomarkers of Alcohol After an Experimental Administration of Alcohol Simulating a "Binge Drinking" Episode (BINGE)

Primary Purpose

Binge Drinking, Alcohol-Related Disorders

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Alcohol

About this trial

This is an interventional basic science trial for Binge Drinking focused on measuring "binge drinking", "alcohol", "pharmacokinetics", "biomarkers"

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Understanding and accepting the study procedures and signing the informed consent.
Male and females healthy volunteers (18-35 years old)
Clinical history and physical examination demonstrating no organic or psychiatric disorders.
The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
Body weight between 60 and 85 kilograms for men and between 50 and 65 kg in for women. Lower or higher weights will be accepted, if the researchers considered that do not pose a risk to the subjects and do not interfere with the objectives of the study.
BMI between 19-27 kg/m². Lower or higher BMIs will be allow, if the researchers considered that do not pose a risk to the subjects and do not interfere with the objectives of the study.
Recreational use of alcohol at least 1 standard unit alcohol (standard drink)/day (accumulated in the week) and previous experiences in drunkenness and binge-drinking.
Women with a regular menstrual cycle lasting between 26-32 days.

Exclusion Criteria:

Not fill the inclusion criteria.
History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
Present history of substance use disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM)-IV (except for nicotine). Past history of mild substance use disorder (corresponding to abuse substance according to DSM-IV) could be included.
Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
Having suffered any organic disease or major surgery in the three months prior to the study start.
Subjects with intolerance or serious adverse reactions to alcohol. Asian subjects with no intolerance or serious adverse reactions to alcohol could be included.
Regular use of any drug in the month prior to the study sessions.The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
Daily consumption >10 cigarettes.
Daily consumption >20 grams of alcohol in women and >40 grams of alcohol in men.

Daily consumption >5 coffees, tea, cola refreshment or other stimulating drinks or containing xanthines in the three months prior to the study start.

Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
Subjects with positive serology to Hepatitis B, C or HIV.
Pregnant, breastfeeding women or those not use an method of contraception or not use an effective contraceptive (i.e. abstinence, intrauterine devices, barrier methods or partner vasectomy).

Sites / Locations

Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (HUGTP-IGTP)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

70 grams alcohol

100 grams alcohol

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Area Under the Concentration-Time Curve (AUC 0-24h) of alcohol concentration in blood.

Calculation of AUC of the concentrations of alcohol in blood.

Secondary Outcome Measures

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.

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)

Elimination half-life f the concentrations of alcohol in blood.

Calculation of elimination half-life of the concentrations of alcohol in blood.

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)

Change in blood pressure

Blood pressure measured in mmHg

Change in heart rate

Heart rate measured in beats per minute

Change in oral temperature

Oral temperature measured in Celsius degrees

Change in drunkenness

Drunkenness will be measured using rate scales

Change in subjective effects

Subjective effects will be measured using rate scales

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.

Full Information

NCT ID

NCT03931018

First Posted

February 8, 2019

Last Updated

April 25, 2019

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

Germans Trias i Pujol Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03931018

Brief Title

Biomarkers of Alcohol After an Experimental Administration of Alcohol Simulating a "Binge Drinking" Episode

Acronym

BINGE

Official Title

Biomarkers of Acute Damage and Exposure/Consumption to Alcohol After an Experimental Administration of Alcohol Simulating a "Binge Drinking" Episode in Young Adults

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

Germans Trias i Pujol Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge Drinking, Alcohol-Related Disorders

Keywords

"binge drinking", "alcohol", "pharmacokinetics", "biomarkers"

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two groups (one receiving 70 g and other receiving 100 g)

Masking

Participant

Masking Description

Simple Blind

Allocation

Non-Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

70 grams alcohol

Arm Type

Experimental

Arm Description

Arm Title

100 grams alcohol

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Alcohol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Area Under the Concentration-Time Curve (AUC 0-24h) of alcohol concentration in blood.

Description

Calculation of AUC of the concentrations of alcohol in blood.

Time Frame

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.

Secondary Outcome Measure Information:

Title

Area Under the Concentration-Time Curve (AUC 0-24h) of biomarkers of acute damage and exposure/consumption in blood.

Description

Calculation of AUC of the concentrations of other biomarkers of exposure/consumption in blood.

Time Frame

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

Title

Cumulative amount of biomarkers of exposure/consumption excreted into urine up to collection time of last measurable concentration.

Description

Urine will be collected in intervals and the total amount of biomarkers of exposure/consumption will be calculated (ethylglucuronide and ethylsulfate)

Time Frame

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

Title

Elimination half-life f the concentrations of alcohol in blood.

Description

Calculation of elimination half-life of the concentrations of alcohol in blood.

Time Frame

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

Title

Area Under the Concentration-Time Curve (AUC 0-24h) of alcohol in breath (BrAC)

Description

Calculation of AUC of the concentrations of alcohol in breath (BrAC)

Time Frame

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

Title

Change in blood pressure

Description

Blood pressure measured in mmHg

Time Frame

From pre-dose (baseline, 0 hours) to 24 hours post-dose

Title

Change in heart rate

Description

Heart rate measured in beats per minute

Time Frame

From pre-dose (baseline, 0 hours) to 24 hours post-dose

Title

Change in oral temperature

Description

Oral temperature measured in Celsius degrees

Time Frame

From pre-dose (baseline, 0 hours) to 24 hours post-dose

Title

Change in drunkenness

Description

Drunkenness will be measured using rate scales

Time Frame

From pre-dose (baseline, 0 hours) to 24 hours post-dose.

Title

Change in subjective effects

Description

Subjective effects will be measured using rate scales

Time Frame

From pre-dose (baseline, 0 hours) to 24 hours post-dose.

Title

Number of Participants with Serious and Non-Serious Adverse Events

Description

Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators.

Time Frame

From pre-dose (baseline, 0 hours) to 21 days post-dose.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Understanding and accepting the study procedures and signing the informed consent. Male and females healthy volunteers (18-35 years old) Clinical history and physical examination demonstrating no organic or psychiatric disorders. The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically. Body weight between 60 and 85 kilograms for men and between 50 and 65 kg in for women. Lower or higher weights will be accepted, if the researchers considered that do not pose a risk to the subjects and do not interfere with the objectives of the study. BMI between 19-27 kg/m². Lower or higher BMIs will be allow, if the researchers considered that do not pose a risk to the subjects and do not interfere with the objectives of the study. Recreational use of alcohol at least 1 standard unit alcohol (standard drink)/day (accumulated in the week) and previous experiences in drunkenness and binge-drinking. Women with a regular menstrual cycle lasting between 26-32 days. Exclusion Criteria: Not fill the inclusion criteria. History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs. Present history of substance use disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM)-IV (except for nicotine). Past history of mild substance use disorder (corresponding to abuse substance according to DSM-IV) could be included. Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks. Having suffered any organic disease or major surgery in the three months prior to the study start. Subjects with intolerance or serious adverse reactions to alcohol. Asian subjects with no intolerance or serious adverse reactions to alcohol could be included. Regular use of any drug in the month prior to the study sessions.The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session. Daily consumption >10 cigarettes. Daily consumption >20 grams of alcohol in women and >40 grams of alcohol in men. Daily consumption >5 coffees, tea, cola refreshment or other stimulating drinks or containing xanthines in the three months prior to the study start. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed. Subjects with positive serology to Hepatitis B, C or HIV. Pregnant, breastfeeding women or those not use an method of contraception or not use an effective contraceptive (i.e. abstinence, intrauterine devices, barrier methods or partner vasectomy).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Angels Fortes, BS

Phone

34 93 497 89 56

ceic.germanstrias@gencat.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Esther Papaseit, MD, PhD

Organizational Affiliation

Germans Trias i Pujol Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (HUGTP-IGTP)

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Esther Papaseit, MD

Phone

34 93 497 88 65

epapaseit.germanstrias@gencat.cat

First Name & Middle Initial & Last Name & Degree

Magi Farre, MD

Phone

34 93 497 88 65

mfarre.germanstrias@gencat.cat

First Name & Middle Initial & Last Name & Degree

Esther Papaseit, MD,PhD

First Name & Middle Initial & Last Name & Degree

Magi Farre, MD, PhD

First Name & Middle Initial & Last Name & Degree

Clara Perez-Maña, MD, PhD

First Name & Middle Initial & Last Name & Degree

Soraya Martin, RN

First Name & Middle Initial & Last Name & Degree

Lourdes Poyatos, BS

First Name & Middle Initial & Last Name & Degree

Susana Malumbres, MD

First Name & Middle Initial & Last Name & Degree

Ana Maria Barriocanal, MD, PHD

12. IPD Sharing Statement

Learn more about this trial

Biomarkers of Alcohol After an Experimental Administration of Alcohol Simulating a "Binge Drinking" Episode

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