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

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ClinicalTrials.gov Identifier: NCT03931018
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Germans Trias i Pujol Hospital
Information provided by (Responsible Party):
Fundació Institut Germans Trias i Pujol

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 Intervention/treatment Phase
Binge Drinking Alcohol-Related Disorders Other: Alcohol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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)
Masking Description: Simple Blind
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 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

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.




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931018


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

Locations
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Spain
Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (HUGTP-IGTP) Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Esther Papaseit, MD    34 93 497 88 65    epapaseit.germanstrias@gencat.cat   
Contact: Magi Farre, MD    34 93 497 88 65    mfarre.germanstrias@gencat.cat   
Principal Investigator: Esther Papaseit, MD,PhD         
Sub-Investigator: Magi Farre, MD, PhD         
Sub-Investigator: Clara Perez-Maña, MD, PhD         
Sub-Investigator: Soraya Martin, RN         
Sub-Investigator: Lourdes Poyatos, BS         
Sub-Investigator: Susana Malumbres, MD         
Sub-Investigator: Ana Maria Barriocanal, MD, PHD         
Sponsors and Collaborators
Fundació Institut Germans Trias i Pujol
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Esther Papaseit, MD, PhD Germans Trias i Pujol Hospital
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Responsible Party: Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT03931018    
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

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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:
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Alcohol-Related Disorders
Binge Drinking
Binge-Eating Disorder
Feeding and Eating Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Drinking
Drinking Behavior