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Alcohol ConsumptionPhase 1NCT02311686

Non-oxidative Metabolite Profiles After Increasing Doses of Ethanol

A Phase 1 study testing 10 g ethanol, 20 g ethanol and 40 g ethanol in people with Alcohol Consumption and Healthy, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of increasing doses of alcohol in adult subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Consumption, Healthy
What is being tested?
10 g ethanol, 20 g ethanol and 40 g ethanol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteSpain
Study dates
Dec 2014to May 2016
Phase
Phase 1
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Understand and accept the study's procedures and sign an informed consent form
  • No evidence of somatic or psychiatric disorders as per past medical history and physical examination
  • EKG, blood and urine tests taken before entry into the study within the normal range. Minor and transient abnormalities may be acceptable if, according to the Principal Investigator's criterion and the state of the art, they are felt to have no clinical relevance, entail no danger to the participant, and don't interfere with the product's assessment. These abnormalities and their non-relevance must be specifically justified in writing)
  • Body mass index (BMI=weight/heigth2) between 19 and 29 kg/m2, weight between 50 and 100 kg (for the 60 and 80 g doses, subjects will be required to weigh a minimum of 67 kg)
  • For premenopausal females, a regular menstrual cycle of 26-32 days duration.
  • Social or recreational alcohol consumption of at least 1 unit per day (or its equivalent [7 units] over the whole week) and having experienced drunkenness several times

Who cannot join

  • Evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of the drug or symptoms suggestive of drug-induced gastrointestinal irritation
  • Previous psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs
  • Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks
  • Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial
  • Individuals intolerant or having experienced a severe adverse reaction to alcohol
  • Having regularly taken medication in the month before the trial, except for vitamins, herb-based remedies, dietary supplements that if, according to the Principal Investigator or his appointed collaborators' opinion, they pose no threat to the subjects and they won't interfere with the study's objectives. Single doses of symptomatic drugs taken during the week before the experimental session will not constitute an exclusion criterion if it can be assumed that it has been completely eliminated on the day of the experimental session
Show all 13Show fewer
  • Smokers of >10 cigarettes/day
  • Consumption of >20 g/day of alcohol (females) or of >40 g/day (males)
  • Daily consumption of more than 5 coffees, teas, cola drinks or other stimulant or xanthine-containing beverages in the 3 months prior to inclusion in the study
  • Hepatitis B, hepatitis C or human immunodeficiency virus-positive individuals
  • Pregnant or lactating women, or those using hormonal or unreliable contraceptive methods during the study period. Complete abstinence, intrauterine devices, double barrier methods or a vasectomized sexual partner will be considered acceptable
  • Women with amenorrhea or suffering severe premenstrual syndrome
  • Individuals of Asian ascent

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Parc de Salut Mar (IMIM)

    Barcelona, Barcelona, 08003

Other trials in Spain

About this study

Official title: Identifying the Profile of the Main Non-oxidative Biomarkers of Alcohol (Ethyl Glucuronide, Ethyl Sulphate, Fatty Acid Ethyl Esters) After the Experimental Exposure to Increasing Doses of Alcohol in Adults.

The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of increasing doses of alcohol in adult subjects.

Read the detailed description

The abuse of alcohol causes serious health and social problems. Alcohol consumption can be monitored by detecting biomarkers. In current practice indirect biomarkers (mean corpuscular volume, transaminases, gammaglutamyl or carbohydrate-deficient transferrin) are used, although direct biomarkers of alcohol, including alcohol itself and metabolites also exist.

Biomarkers of alcohol consumption are used as tools to prevent health and social problems related with alcohol, allowing the identification of subjects at risk of abuse, dependence or withdrawal and to assess the efficacy of treatments for alcohol dependence.

Non-oxidative metabolites (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) have longer biological half-life than ethanol and accumulate in tissues after consumption.

The objective of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of increasing doses of alcohol in adult subjects.

Subjects will be genotyped for genetic polymorphisms of proteins related to ethanol metabolism and effects (as alcohol dehydrogenase and aldehyde dehydrogenase), and the genotypes will be used to evaluate their influence in the results.

Being tested
10 g ethanol, 20 g ethanol, 40 g ethanol, 60 g ethanol, 80 g ethanol
Keywords
Ethanol, Fatty acid ethyl esters, Ethyl glucoronide, Ethyl sulphate, Pharmacokinetics
Medical subject headings
Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10 g ethanolDietary supplement

    Also called Vodka Absolut®

    Alcohol single oral dose

  • 20 g ethanolDietary supplement

    Also called Vodka Absolut®

    Alcohol single oral dose

  • 40 g ethanolDietary supplement

    Also called Vodka Absolut®

    Alcohol single oral dose

  • 60 g ethanolDietary supplement

    Also called Vodka Absolut®

    Alcohol single oral dose

  • 80 g ethanolDietary supplement

    Also called Vodka Absolut®

    Alcohol single oral dose

Study groups in NCT02311686
Study groupRoleWhat they receive
10 g ethanolExperimentalSubjects will be required to drink a dilution of 31 mL of vodka in 369 mL of lemon-flavored water in 15 minutes.
Receives: Dietary Supplement: 10 g ethanol
20 g ethanolExperimentalSubjects will be required to drink a dilution of 63 mL of vodka in 337 mL of lemon-flavored water in 15 minutes.
Receives: Dietary Supplement: 20 g ethanol
40 g ethanolExperimentalSubjects will be required to drink a dilution of 125 mL of vodka in 275 mL of lemon-flavored water in 15 minutes.
Receives: Dietary Supplement: 40 g ethanol
60 g ethanolExperimentalSubjects will be required to drink a dilution of 188 mL of vodka in 212 mL of lemon-flavored water in 15 minutes.
Receives: Dietary Supplement: 60 g ethanol
80 g ethanolExperimentalSubjects will be required to drink a dilution of 250 mL of vodka in 150 mL of lemon-flavored water in 15 minutes.
Receives: Dietary Supplement: 80 g ethanol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration-Time Curve (AUC 0-24h)

    Calculation of the AUC for plasma fatty acid ethyl esters (palmitic, stearic, linoleic and oleic acid ethyl esters) concentrations. Blood samples will be obtained baseline and at 0,25, 0,50, 0,75,1, 1,25, 1,50, 1,75, 2, 2,5, 3, 3,5, 4, 5, 6, 8, 10, 24h. Additional samples will be collect at 72 h and 1 week, 1 and 2 months after administration. At 3 months a sample will be obtained in selected participants.

    Measured: From baseline to 24 hours after administration

Secondary outcomes (10)

  1. Area Under the Concentration-Time Curve (AUC 0-24h)

    Calculation of the AUC for plasma and saliva concentrations of ethanol and its non-oxidative metabolites ethyl sulphate and ethyl glucoronide. Blood samples will be obtained baseline and at 0,25, 0,50, 0,75,1, 1,25, 1,50, 1,75, 2, 2,5, 3, 3,5, 4, 5, 6, 8, 10, 24. Additional samples will be collected at 72 h and 1 week, 1 month and 2 months after administration. At 3 months a sample in selected participants. Saliva samples at baseline and 0,5, 1, 2, 3, 4, 6, 10 and 24 h after administration

    Measured: From baseline to 24 hours after administration

  2. Cumulative amount of drug excreted into urine up to collection time of last measurable concentration

    Urine will be collected in the following intervals 0-6h, 6-12h, 12-24h, 24-48h, 48-72h and the total amount of ethanol and its non-oxidative metabolites ethyl sulphate and ethyl glucoronide will be calculated.

    Measured: From baseline to 72 hours after administration

  3. Elimination half-life

    Calculation of elimination half-life from ethanol and its non-oxidative metabolites (fatty acid ethyl esters, ethyl sulphate and ethyl glucoronide) concentrations in plasma

    Measured: From baseline to 24 hours after administration

  4. Fatty acid ethyl esters and ethyl glucoronide hair concentrations

    Concentrations of fatty acid ethyl esters and ethyl glucoronide in hair at baseline, one and two month after administration. An additional sample at 3 months in selected participants.

    Measured: Baseline, 1 and 2 months after administration

  5. Change in subjective effects of ethanol

    Participants will self-report their experience on a visual analogue scale of drunkenness and Biphasic alcohol effects scale (BAES) at baseline and 0.5,0.75,1,1.5,2,4,6,8,10 after administration.

    Measured: From baseline to 10 hours after administration

  6. 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 baseline to 24 hours after administration

  7. Change in Addiction Research Center Inventory (ARCI)

    ARCI will be administered baseline and 10 h after administration (subjects should answer at 10 h remembering their experience at the moment of maximum effects)

    Measured: From baseline to 10 h after administration

  8. Change in Evaluation of Subjective Effects of Substances with Abuse Potential (VESSPA)

    VESSPA will be administered baseline and 10 h after administration (subjects should answer at 10 h remembering their experience at the moment of maximum effects)

    Measured: From baseline to 10 h after administration

  9. Ethanol dose identification questionaire

    Participants should guess the dose they have ingested during the experimental session among 5 options (10, 20, 40, 60 and 80 g of ethanol)

    Measured: 10 h after administration

  10. Urinary drug concentrations

    Urinary concentrations of ethanol and its non-oxidative metabolites ethyl sulphate and ethyl glucoronide will measured at 1 week, 1 and 2 months after administration (3 months in selected subjects)

    Measured: From 1 week to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02311686
Sponsor's protocol ID
Biomarcadores/PNSD/1
Status last verified
May 2016
First submitted
3 Dec 2014
Last updated
16 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Blaha M, Aaslid R, Douville CM, Correra R, Newell DW. Cerebral blood flow and dynamic cerebral autoregulation during ethanol intoxication and hypercapnia. J Clin Neurosci. 2003 Mar;10(2):195-8. doi: 10.1016/s0967-5868(02)00126-1.

    PubMed 12637048

  • Best CA, Sarkola T, Eriksson CJ, Cluette-Brown JE, Laposata M. Increased plasma fatty acid ethyl ester levels following inhibition of oxidative metabolism of ethanol by 4-methylpyrazole treatment in human subjects. Alcohol Clin Exp Res. 2006 Jul;30(7):1126-31. doi: 10.1111/j.1530-0277.2006.00138.x.

    PubMed 16792559

  • Bottcher M, Beck O, Helander A. Evaluation of a new immunoassay for urinary ethyl glucuronide testing. Alcohol Alcohol. 2008 Jan-Feb;43(1):46-8. doi: 10.1093/alcalc/agm153. Epub 2007 Oct 17.

    PubMed 17942435

  • Cami J, de la Torre R, Garcia-Sevilla L, Ugena B, Knobel H, Segura J. Alcohol antagonism of hypercortisolism induced by naloxone. Clin Pharmacol Ther. 1988 Jun;43(6):599-604. doi: 10.1038/clpt.1988.82.

    PubMed 3378381

  • Di Castelnuovo A, Costanzo S, Bagnardi V, Donati MB, Iacoviello L, de Gaetano G. Alcohol dosing and total mortality in men and women: an updated meta-analysis of 34 prospective studies. Arch Intern Med. 2006 Dec 11-25;166(22):2437-45. doi: 10.1001/archinte.166.22.2437.

    PubMed 17159008

  • Doyle KM, Cluette-Brown JE, Dube DM, Bernhardt TG, Morse CR, Laposata M. Fatty acid ethyl esters in the blood as markers for ethanol intake. JAMA. 1996 Oct 9;276(14):1152-6.

    PubMed 8827968

  • Farre M, de la Torre R, Llorente M, Lamas X, Ugena B, Segura J, Cami J. Alcohol and cocaine interactions in humans. J Pharmacol Exp Ther. 1993 Sep;266(3):1364-73.

    PubMed 8371143

  • Halter CC, Dresen S, Auwaerter V, Wurst FM, Weinmann W. Kinetics in serum and urinary excretion of ethyl sulfate and ethyl glucuronide after medium dose ethanol intake. Int J Legal Med. 2008 Mar;122(2):123-8. doi: 10.1007/s00414-007-0180-8. Epub 2007 Jun 9.

    PubMed 17558515

  • Hoiseth G, Bernard JP, Karinen R, Johnsen L, Helander A, Christophersen AS, Morland J. A pharmacokinetic study of ethyl glucuronide in blood and urine: applications to forensic toxicology. Forensic Sci Int. 2007 Oct 25;172(2-3):119-24. doi: 10.1016/j.forsciint.2007.01.005. Epub 2007 Feb 16.

    PubMed 17306943

  • Hoiseth G, Bernard JP, Stephanson N, Normann PT, Christophersen AS, Morland J, Helander A. Comparison between the urinary alcohol markers EtG, EtS, and GTOL/5-HIAA in a controlled drinking experiment. Alcohol Alcohol. 2008 Mar-Apr;43(2):187-91. doi: 10.1093/alcalc/agm175. Epub 2008 Jan 29.

    PubMed 18230699

  • Holford NH. Clinical pharmacokinetics of ethanol. Clin Pharmacokinet. 1987 Nov;13(5):273-92. doi: 10.2165/00003088-198713050-00001.

    PubMed 3319346

  • Johnson RD, Horowitz M, Maddox AF, Wishart JM, Shearman DJ. Cigarette smoking and rate of gastric emptying: effect on alcohol absorption. BMJ. 1991 Jan 5;302(6767):20-3. doi: 10.1136/bmj.302.6767.20.

    PubMed 1991182

  • Jones MK, Jones BM. Ethanol metabolism in women taking oral contraceptives. Alcohol Clin Exp Res. 1984 Jan-Feb;8(1):24-8. doi: 10.1111/j.1530-0277.1984.tb05026.x.

    PubMed 6370017

  • Kalant H, LeBlanc AE, Wilson A, Homatidis S. Sensorimotor and physiological effects of various alcoholic beverages. Can Med Assoc J. 1975 Apr 19;112(8):953-8.

    PubMed 1131767

  • King AR, Hunter PJ. Alcohol elimination at low blood concentrations among women taking combined oral contraceptives. J Stud Alcohol. 2005 Nov;66(6):738-44. doi: 10.15288/jsa.2005.66.738.

    PubMed 16459935

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 10 g ethanol, 20 g ethanol and 40 g ethanol in people with Alcohol Consumption and Healthy, run by Parc de Salut Mar 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 6 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: finished, as of the sponsor's last update on 16 May 2016. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-Time Curve (AUC 0-24h) (time frame: From baseline to 24 hours after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02311686, which also lists 30 linked publications.

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 16 May 2016.

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