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

April 25, 2019 updated by: Fundació Institut Germans Trias i Pujol

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (HUGTP-IGTP)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esther Papaseit, MD,PhD
        • Sub-Investigator:
          • Clara Perez-Maña, MD, PhD
        • Sub-Investigator:
          • Susana Malumbres, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: 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.
Experimental: 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)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve (AUC 0-24h) of alcohol concentration 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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve (AUC 0-24h) of biomarkers of acute damage and 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
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
Cumulative amount of biomarkers of exposure/consumption excreted into urine up to collection time of last measurable concentration.
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
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.
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
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)
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
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
Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose
Blood pressure measured in mmHg
From pre-dose (baseline, 0 hours) to 24 hours post-dose
Change in heart rate
Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose
Heart rate measured in beats per minute
From pre-dose (baseline, 0 hours) to 24 hours post-dose
Change in oral temperature
Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose
Oral temperature measured in Celsius degrees
From pre-dose (baseline, 0 hours) to 24 hours post-dose
Change in drunkenness
Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose.
Drunkenness will be measured using rate scales
From pre-dose (baseline, 0 hours) to 24 hours post-dose.
Change in subjective effects
Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose.
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
Time Frame: From pre-dose (baseline, 0 hours) to 21 days post-dose.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

Germans Trias i Pujol Hospital

Investigators

  • Principal Investigator: Esther Papaseit, MD, PhD, Germans Trias I Pujol Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUGTP/BINGE/PNSD/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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