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

NCT ID: NCT03931018

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-03-01

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.

Conditions

Binge Drinking; Alcohol-Related Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

70 grams alcohol

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)

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: 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.

100 grams alcohol

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)

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: 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.

Interventions

Alcohol

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.

Intervention Type: OTHER

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.

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: collaborator

Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Papaseit, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

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

Badalona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Angels Fortes, BS

Role: CONTACT

ceic.germanstrias@gencat.cat

34 93 497 89 56

Facility Contacts

Esther Papaseit, MD

Role: primary

epapaseit.germanstrias@gencat.cat

34 93 497 88 65

Magi Farre, MD

Role: backup

mfarre.germanstrias@gencat.cat

34 93 497 88 65

Other Identifiers

HUGTP/BINGE/PNSD/1

Identifier Type: -

Identifier Source: org_study_id