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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03931018

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted April 29, 2019

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.

  • Condition or Disease:Binge Drinking
    Alcohol-Related Disorders
  • Intervention/Treatment: Other: Alcohol
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 36 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Two groups (one receiving 70 g and other receiving 100 g)
  • Masking: Single (Participant)
  • Primary Purpose: Basic Science
  • 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
  • Actual Study Start Date: December 2017
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: March 2020
Arms and interventions
Arm Intervention/treatment
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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)
  • 3. 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.
  • 4. 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)
  • 5. Change in blood pressure [ Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose ]
    Blood pressure measured in mmHg
  • 6. Change in heart rate [ Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose ]
    Heart rate measured in beats per minute
  • 7. Change in oral temperature [ Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose ]
    Oral temperature measured in Celsius degrees
  • 8. Change in drunkenness [ Time Frame: From pre-dose (baseline, 0 hours) to 24 hours post-dose. ]
    Drunkenness will be measured using rate scales
  • 9. 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
  • 10. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 35 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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).

Contacts and Locations
Contacts

Contact: Angels Fortes, BS 34 93 497 89 56 ceic.germanstrias@gencat.cat

Locations

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

Sponsors and Collaborators

Fundació Institut Germans Trias i Pujol

Germans Trias i Pujol Hospital

Investigators

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

More Information
  • Responsible Party: Fundació Institut Germans Trias i Pujol
  • ClinicalTrials.gov Identifier: NCT03931018 History of Changes
  • Other Study ID Numbers: HUGTP/BINGE/PNSD/1
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: April 29, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Fundació Institut Germans Trias i Pujol: "binge drinking"
    "alcohol"
    "pharmacokinetics"
    "biomarkers"
  • Additional relevant MeSH terms: Alcohol-Related Disorders
    Binge Drinking
    Binge-Eating Disorder