Binge DrinkingBINGENCT03931018
Biomarkers of Alcohol After an Experimental Administration of Alcohol Simulating a "Binge Drinking" Episode
A study testing Alcohol in people with Binge Drinking and Alcohol-Related Disorders, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking, Alcohol-Related Disorders
- What is being tested?
- Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (HUGTP-IGTP)
Badalona, Barcelona, 08916
Esther Papaseit, MD, 34 93 497 88 65, epapaseit.germanstrias@gencat.cat
Magi Farre, MD, 34 93 497 88 65, mfarre.germanstrias@gencat.cat
About this study
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
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.
Read the 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
- Being tested
- Alcohol
- Keywords
- "binge drinking", "alcohol", "pharmacokinetics", "biomarkers"
- Medical subject headings
- Binge Drinking, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve (AUC 0-24h) of alcohol concentration in blood.
Calculation of AUC of the concentrations of alcohol in blood.
Measured: 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.
Calculation of AUC of the concentrations of other biomarkers of exposure/consumption in blood.
Measured: 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.
Urine will be collected in intervals and the total amount of biomarkers of exposure/consumption will be calculated (ethylglucuronide and ethylsulfate)
Measured: 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.
Calculation of elimination half-life of the concentrations of alcohol in blood.
Measured: 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)
Calculation of AUC of the concentrations of alcohol in breath (BrAC)
Measured: 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
Blood pressure measured in mmHg
Measured: From pre-dose (baseline, 0 hours) to 24 hours post-dose
Change in heart rate
Heart rate measured in beats per minute
Measured: From pre-dose (baseline, 0 hours) to 24 hours post-dose
Change in oral temperature
Oral temperature measured in Celsius degrees
Measured: From pre-dose (baseline, 0 hours) to 24 hours post-dose
Change in drunkenness
Drunkenness will be measured using rate scales
Measured: From pre-dose (baseline, 0 hours) to 24 hours post-dose.
Change in subjective effects
Subjective effects will be measured using rate scales
Measured: From pre-dose (baseline, 0 hours) to 24 hours post-dose.
Number of Participants with Serious and Non-Serious Adverse Events
Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators.
Measured: From pre-dose (baseline, 0 hours) to 21 days post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Dec 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups (one receiving 70 g and other receiving 100 g)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
- Investigators
- Esther Papaseit, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931018
- Sponsor's protocol ID
- HUGTP/BINGE/PNSD/1
- Acronym
- BINGE
- Status last verified
- Apr 2019
- First submitted
- 8 Feb 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03931018
- Acronym / sponsor ID
- BINGE / HUGTP/BINGE/PNSD/1
- Conditions
- Binge Drinking, Alcohol-Related Disorders
- Keywords
- "binge drinking", "alcohol", "pharmacokinetics", "biomarkers"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups (one receiving 70 g and other receiving 100 g)
| Arm | Type | Receives |
|---|---|---|
| 70 grams alcohol | Experimental | Other: AlcoholMales 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) |
| 100 grams alcohol | Experimental | Other: AlcoholMales: 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholAdministration 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. | Other | 100 grams alcohol, 70 grams alcohol |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
Change in blood pressure
Time frame: 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
Change in oral temperature
Time frame: 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.
Change in subjective effects
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Papaseit, MD, PhD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol in people with Binge Drinking and Alcohol-Related Disorders, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angels Fortes, BS (34 93 497 89 56, ceic.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.