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Non-oxidative Metabolite Profiles After Increasing Doses of Ethanol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311686
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Clara Pérez, Parc de Salut Mar

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Healthy Dietary Supplement: 10 g ethanol Dietary Supplement: 20 g ethanol Dietary Supplement: 40 g ethanol Dietary Supplement: 60 g ethanol Dietary Supplement: 80 g ethanol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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.
Study Start Date : December 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: 10 g ethanol
Alcohol single oral dose
Other Name: Vodka Absolut®

Experimental: 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.
Dietary Supplement: 20 g ethanol
Alcohol single oral dose
Other Name: Vodka Absolut®

Experimental: 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.
Dietary Supplement: 40 g ethanol
Alcohol single oral dose
Other Name: Vodka Absolut®

Experimental: 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.
Dietary Supplement: 60 g ethanol
Alcohol single oral dose
Other Name: Vodka Absolut®

Experimental: 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.
Dietary Supplement: 80 g ethanol
Alcohol single oral dose
Other Name: Vodka Absolut®




Primary Outcome Measures :
  1. Area Under the Concentration-Time Curve (AUC 0-24h) [ Time Frame: From baseline to 24 hours after administration ]
    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.


Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve (AUC 0-24h) [ Time Frame: From baseline to 24 hours after administration ]
    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

  2. Cumulative amount of drug excreted into urine up to collection time of last measurable concentration [ Time Frame: From baseline to 72 hours after administration ]
    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.

  3. Elimination half-life [ Time Frame: From baseline to 24 hours after administration ]
    Calculation of elimination half-life from ethanol and its non-oxidative metabolites (fatty acid ethyl esters, ethyl sulphate and ethyl glucoronide) concentrations in plasma

  4. Fatty acid ethyl esters and ethyl glucoronide hair concentrations [ Time Frame: Baseline, 1 and 2 months after administration ]
    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.

  5. Change in subjective effects of ethanol [ Time Frame: From baseline to 10 hours after administration ]
    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.

  6. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: From baseline to 24 hours after administration ]
    Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators

  7. Change in Addiction Research Center Inventory (ARCI) [ Time Frame: From baseline to 10 h after administration ]
    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)

  8. Change in Evaluation of Subjective Effects of Substances with Abuse Potential (VESSPA) [ Time Frame: From baseline to 10 h after administration ]
    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)

  9. Ethanol dose identification questionaire [ Time Frame: 10 h after administration ]
    Participants should guess the dose they have ingested during the experimental session among 5 options (10, 20, 40, 60 and 80 g of ethanol)

  10. Urinary drug concentrations [ Time Frame: From 1 week to 2 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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

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): NCT02311686


Locations
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Spain
Parc de Salut Mar (IMIM)
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Study Director: Francina Fonseca, MD, PhD Parc de Salut Mar
Principal Investigator: Clara Pérez, MD, PhD Parc de Salut Mar
Publications:

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Responsible Party: Clara Pérez, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02311686    
Other Study ID Numbers: Biomarcadores/PNSD/1
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Clara Pérez, Parc de Salut Mar:
Ethanol
Fatty acid ethyl esters
Ethyl glucoronide
Ethyl sulphate
Pharmacokinetics
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs