Non-oxidative Metabolite Profiles After Increasing Doses of Ethanol
NCT ID: NCT02311686
Last Updated: 2016-05-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
54 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-12-31
Study Completion Date
2016-05-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Alcohol Consumption
Healthy
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
SINGLE
Participants
Study Groups
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10 g ethanol
Subjects will be required to drink a dilution of 31 mL of vodka in 369 mL of lemon-flavored water in 15 minutes.
Group Type
EXPERIMENTAL
10 g ethanol
Intervention Type
DIETARY_SUPPLEMENT
Alcohol single oral dose
20 g ethanol
Subjects will be required to drink a dilution of 63 mL of vodka in 337 mL of lemon-flavored water in 15 minutes.
Group Type
EXPERIMENTAL
20 g ethanol
Intervention Type
DIETARY_SUPPLEMENT
Alcohol single oral dose
40 g ethanol
Subjects will be required to drink a dilution of 125 mL of vodka in 275 mL of lemon-flavored water in 15 minutes.
Group Type
EXPERIMENTAL
40 g ethanol
Intervention Type
DIETARY_SUPPLEMENT
Alcohol single oral dose
60 g ethanol
Subjects will be required to drink a dilution of 188 mL of vodka in 212 mL of lemon-flavored water in 15 minutes.
Group Type
EXPERIMENTAL
60 g ethanol
Intervention Type
DIETARY_SUPPLEMENT
Alcohol single oral dose
80 g ethanol
Subjects will be required to drink a dilution of 250 mL of vodka in 150 mL of lemon-flavored water in 15 minutes.
Group Type
EXPERIMENTAL
80 g ethanol
Intervention Type
DIETARY_SUPPLEMENT
Alcohol single oral dose
Interventions
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10 g ethanol
Alcohol single oral dose
Intervention Type
DIETARY_SUPPLEMENT
20 g ethanol
Alcohol single oral dose
Intervention Type
DIETARY_SUPPLEMENT
40 g ethanol
Alcohol single oral dose
Intervention Type
DIETARY_SUPPLEMENT
60 g ethanol
Alcohol single oral dose
Intervention Type
DIETARY_SUPPLEMENT
80 g ethanol
Alcohol single oral dose
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
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Vodka Absolut®
Vodka Absolut®
Vodka Absolut®
Vodka Absolut®
Vodka Absolut®
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Parc de Salut Mar
OTHER
Sponsor Role
lead
Responsible Party
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Clara Pérez
PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Francina Fonseca, MD, PhD
Role: STUDY_DIRECTOR
Parc de Salut Mar
Clara Pérez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Parc de Salut Mar
Locations
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Parc de Salut Mar (IMIM)
Barcelona, Barcelona, Spain
Site Status
Countries
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Spain
References
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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.
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BACKGROUND
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.
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BACKGROUND
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.
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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.
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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.
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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.
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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.
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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.
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Holford NH. Clinical pharmacokinetics of ethanol. Clin Pharmacokinet. 1987 Nov;13(5):273-92. doi: 10.2165/00003088-198713050-00001.
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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.
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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.
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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.
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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.
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Kopun M, Propping P. The kinetics of ethanol absorption and elimination in twins and supplementary repetitive experiments in singleton subjects. Eur J Clin Pharmacol. 1977;11(5):337-44. doi: 10.1007/BF00566530.
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Kulig CC, Beresford TP, Everson GT. Rapid, accurate, and sensitive fatty acid ethyl ester determination by gas chromatography-mass spectrometry. J Lab Clin Med. 2006 Mar;147(3):133-8. doi: 10.1016/j.lab.2005.11.006.
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Logue PE, Linnoila M, Wallman L, Erwin CW. Effects of ethanol and psychomotor tests on state anxiety: interaction with menstrual cycle in women. Percept Mot Skills. 1981 Apr;52(2):643-8. doi: 10.2466/pms.1981.52.2.643.
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Martin E, Moll W, Schmid P, Dettli L. The pharmacokinetics of alcohol in human breath, venous and arterial blood after oral ingestion. Eur J Clin Pharmacol. 1984;26(5):619-26. doi: 10.1007/BF00543496.
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Morini L, Marchei E, Vagnarelli F, Garcia Algar O, Groppi A, Mastrobattista L, Pichini S. Ethyl glucuronide and ethyl sulfate in meconium and hair-potential biomarkers of intrauterine exposure to ethanol. Forensic Sci Int. 2010 Mar 20;196(1-3):74-7. doi: 10.1016/j.forsciint.2009.12.035. Epub 2010 Jan 8.
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Morfin JP, Kulig C, Everson G, Beresford T. Controlling for serum albumin level improves the correlation between serum fatty acid ethyl esters and blood ethanol level. Alcohol Clin Exp Res. 2007 Feb;31(2):265-8. doi: 10.1111/j.1530-0277.2006.00302.x.
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Mumenthaler MS, Taylor JL, O'Hara R, Yesavage JA. Gender differences in moderate drinking effects. Alcohol Res Health. 1999;23(1):55-64.
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Pragst F, Rothe M, Moench B, Hastedt M, Herre S, Simmert D. Combined use of fatty acid ethyl esters and ethyl glucuronide in hair for diagnosis of alcohol abuse: interpretation and advantages. Forensic Sci Int. 2010 Mar 20;196(1-3):101-10. doi: 10.1016/j.forsciint.2009.12.028. Epub 2010 Jan 12.
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Rangno RE, Kreeft JH, Sitar DS. Ethanol 'dose-dependent' elimination: Michaelis-Menten v classical kinetic analysis. Br J Clin Pharmacol. 1981 Nov;12(5):667-73. doi: 10.1111/j.1365-2125.1981.tb01287.x.
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BACKGROUND
Sarkola T, Iles MR, Kohlenberg-Mueller K, Eriksson CJ. Ethanol, acetaldehyde, acetate, and lactate levels after alcohol intake in white men and women: effect of 4-methylpyrazole. Alcohol Clin Exp Res. 2002 Feb;26(2):239-45.
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Schroder H, de la Torre R, Estruch R, Corella D, Martinez-Gonzalez MA, Salas-Salvado J, Ros E, Aros F, Flores G, Civit E, Farre M, Fiol M, Vila J, Fernandez-Crehuet J, Ruiz-Gutierrez V, Lapetra J, Saez G, Covas MI; PREDIMED Study Investigators. Alcohol consumption is associated with high concentrations of urinary hydroxytyrosol. Am J Clin Nutr. 2009 Nov;90(5):1329-35. doi: 10.3945/ajcn.2009.27718. Epub 2009 Sep 16.
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Soderberg BL, Sicinska ET, Blodget E, Cluette-Brown JE, Suter PM, Schuppisser T, Vetter W, Laposata M. Preanalytical variables affecting the quantification of fatty acid ethyl esters in plasma and serum samples. Clin Chem. 1999 Dec;45(12):2183-90.
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Wurst FM, Skipper GE, Weinmann W. Ethyl glucuronide--the direct ethanol metabolite on the threshold from science to routine use. Addiction. 2003 Dec;98 Suppl 2:51-61. doi: 10.1046/j.1359-6357.2003.00588.x.
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Wurst FM, Wiesbeck GA, Metzger JW, Weinmann W. On sensitivity, specificity, and the influence of various parameters on ethyl glucuronide levels in urine--results from the WHO/ISBRA study. Alcohol Clin Exp Res. 2004 Aug;28(8):1220-8. doi: 10.1097/01.alc.0000134230.21414.11.
Reference Type
BACKGROUND
Other Identifiers
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Biomarcadores/PNSD/1
Identifier Type: -
Identifier Source: org_study_id
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