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

NCT03931018 | Unknown

• 1 other identifier: HUGTP/BINGE/PNSD/1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Drinking; Alcohol-Related Disorders

Keywords

"binge drinking"; "alcohol"; "pharmacokinetics"; "biomarkers"

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• Area Under the Concentration-Time Curve (AUC 0-24h) of biomarkers of acute damage and 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.

  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.

  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)

  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

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

Study Arms (2)

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)

Other: Alcohol

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)

Other: Alcohol

Interventions

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.

100 grams alcohol; 70 grams alcohol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

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

Badalona, Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Binge Drinking; Alcohol-Related Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Esther Papaseit, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angels Fortes, BS

CONTACT

34 93 497 89 56; ceic.germanstrias@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Simple Blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups (one receiving 70 g and other receiving 100 g)

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: April 29, 2019
• Study Start: December 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 1, 2020
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

ES (1)