N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking
Primary Purpose
Ethanol Intoxication
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
N Acetylcysteine
Lemon juice
Sponsored by

About this trial
This is an interventional prevention trial for Ethanol Intoxication
Eligibility Criteria
Inclusion Criteria: medical students, who regularly attend social gatherings where alcohol is consumed and had already experienced the symptoms of hangover. healthy not pregnant without any chronic diseases not taking any medications. signed informed consent. Exclusion Criteria: drinking after the end of the study taking any other psychoactive substances or took other measures that supposedly could alleviate the hangover symptoms
Sites / Locations
- University Medical Centre Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NAC
PLACEBO
Arm Description
NAC group was given 1.2 g of N-acetylcysteine before and 1.2 g after drinking alcohol
Placebo group was given lemon juice before and after drinking alcohol
Outcomes
Primary Outcome Measures
Alcohol Hangover Severity Scale
In the next morning after drinking (at 6 am; 9 hours after drinking) the volunteers filled out a standardised questionnaire Alcohol Hangover Severity Scale (AHSS), which includes twelve symptoms correlating with veisalgia: palpitation, sweating, confusion, apathy, abdominal pain, shivering, dizziness, nausea, clumsiness, concentration problems, thirst and fatigue.
Every symptom was graded on the scale from 0 to 10 points, where 0 point meant the absence of the symptom and 10 points the extreme severity of the symptom.
The result of the AHSS questionnaire was calculated for every participant as the average number of points from all of the 12 symptoms (minimum average value was 0 points and maximum 10 points).
Change in acetaldehyde level after drinking compared to the baseline value
Quantification of acetaldehyde in blood samples
Change in serum oxidative biomarker level after drinking compared to the baseline value
Quantification of 8-Hydroxydeoxyguanosine and N-epsilon-hexanoyl-lysin in blood samples
Secondary Outcome Measures
Change in serum ethanol level after drinking compared to the baseline value
Quantification of ethanol in blood samples
Change in serum sodium levels after drinking compared to the baseline
Quantification of serum sodium in blood samples
Change in serum potassium levels after drinking compared to the baseline
Quantification of serum potassium in blood samples
Change in serum urea levels after drinking compared to the baseline
Quantification of serum urea in blood samples
Change in serum creatinine levels after drinking compared to the baseline
Quantification of serum creatinine in blood samples
Change in serum creatinine kinase levels after drinking compared to the baseline
Quantification of serum creatinine kinase in blood samples
Change in serum lactate dehydrogenase levels after drinking compared to the baseline
Quantification of serum lactate dehydrogenase in blood samples
Change in serum aspartate and alanine aminotransferase levels after drinking compared to the baseline
Quantification of serum aspartate and alanine aminotransferase in blood samples
Change in serum gamma glutamyl transferase levels after drinking compared to the baseline
Quantification of serum gamma glutamyl transferase in blood samples
Full Information
NCT ID
NCT05911282
First Posted
May 29, 2023
Last Updated
June 20, 2023
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT05911282
Brief Title
N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking
Official Title
N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Alcohol hangover (veisalgia) is a fairly common phenomenon. The pathogenesis of veisalgia is not understood and treatment has not yet been established. Occasionally, students take N-acetylcysteine (NAC) before binge drinking to alleviate hangover. The aim of the study was to evaluate the effect of NAC on serum levels of electrolytes, enzymes, acetaldehyde, oxidative stress biomarkers and symptoms of veisalgia in binge drinking. In this randomised double-blind placebo-controlled study, healthy students were randomly assigned into two groups, one receiving NAC and the other placebo. Blood samples were taken before drinking, 30 minutes after 1.5-hour-long drinking and in the subsequent morning. Serum levels of electrolytes, urea, enzymes, ethanol, acetaldehyde, 8-Hydroxydeoxyguanosine (8-OHdG) and N-epsilon-hexanoyl-lysine were measured. The participants completed the Acute Hangover Severity Scale (AHSS) based on symptoms.
Detailed Description
On the study day, the participants met at the study location with the investigator at 6.pm. In the beginning they all ate two pizza slices. They filled out a pre-drinking evaluation form about veisalgia (score 1 - 10) and specific symptoms (score 1 - 10). They performed a breath alcohol test with Dräger Alcotest 6820 to exclude volunteers who had been drinking before the study. The registered nurses took blood samples before drinking.
Volunteers were randomly assigned into two groups, one receiving NAC (1.2 g before and 1.2 g after drinking alcohol), and the other placebo. Each participant received an identification number, randomisation was done by a computer. The study began at 7 pm, when they drank the contents of a numbered cup with NAC or placebo corresponding to their number. The researchers and volunteers on the scene were not aware which cups contain NAC or placebo. Afterwards they drank 40 %, v/v, gin mixed with tonic according to the participant's preferences. The drinking was calm. They were mostly sitting and did not participate in any physical activity such as dancing. No other legal or illegal substances or medications were taken during the study.
The drinking ended at 8.30 pm. The nurses took the second blood sample 30 minutes after 1.5-hour-long drinking. The volunteers also performed the second breath alcohol test.
At 9 pm, they were given the second cup with 1.2 g of NAC or placebo corresponding to their randomized number. The latest one hour after the second blood sample was taken all the participants went to sleep.
In the next morning at 6 am (9 hours after drinking) the third blood sample was taken in all volunteers. They performed the third breath alcohol test and filled out a post-drinking form about veisalgia (score 1 - 10), specific symptoms (score 1 - 10), and Alcohol Hangover Severity Scale (AHSS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ethanol Intoxication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAC
Arm Type
Experimental
Arm Description
NAC group was given 1.2 g of N-acetylcysteine before and 1.2 g after drinking alcohol
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Placebo group was given lemon juice before and after drinking alcohol
Intervention Type
Drug
Intervention Name(s)
N Acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
The study began at 7 pm, when the volunteers in NAC group drank the contents of a numbered cup with NAC (1.2 g of NAC). At 9 pm, they were given the second cup with 1.2 g of NAC corresponding to their randomized number.
The cups with pure substance NAC were prepared and numbered by the physician not attending the drinking just before the study.
Intervention Type
Other
Intervention Name(s)
Lemon juice
Other Intervention Name(s)
placebo
Intervention Description
The study began at 7 pm, when the volunteers in placebo group drank the contents of a numbered cup with lemon juice. At 9 pm, they were given the second cup with lemon juice corresponding to their randomized number.
The cups with lemon juice were prepared and numbered by the physician not attending the drinking just before the study.
Primary Outcome Measure Information:
Title
Alcohol Hangover Severity Scale
Description
In the next morning after drinking (at 6 am; 9 hours after drinking) the volunteers filled out a standardised questionnaire Alcohol Hangover Severity Scale (AHSS), which includes twelve symptoms correlating with veisalgia: palpitation, sweating, confusion, apathy, abdominal pain, shivering, dizziness, nausea, clumsiness, concentration problems, thirst and fatigue.
Every symptom was graded on the scale from 0 to 10 points, where 0 point meant the absence of the symptom and 10 points the extreme severity of the symptom.
The result of the AHSS questionnaire was calculated for every participant as the average number of points from all of the 12 symptoms (minimum average value was 0 points and maximum 10 points).
Time Frame
next morning after drinking (at 6 am; 9 hours after drinking)
Title
Change in acetaldehyde level after drinking compared to the baseline value
Description
Quantification of acetaldehyde in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum oxidative biomarker level after drinking compared to the baseline value
Description
Quantification of 8-Hydroxydeoxyguanosine and N-epsilon-hexanoyl-lysin in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Secondary Outcome Measure Information:
Title
Change in serum ethanol level after drinking compared to the baseline value
Description
Quantification of ethanol in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum sodium levels after drinking compared to the baseline
Description
Quantification of serum sodium in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum potassium levels after drinking compared to the baseline
Description
Quantification of serum potassium in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum urea levels after drinking compared to the baseline
Description
Quantification of serum urea in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum creatinine levels after drinking compared to the baseline
Description
Quantification of serum creatinine in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum creatinine kinase levels after drinking compared to the baseline
Description
Quantification of serum creatinine kinase in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum lactate dehydrogenase levels after drinking compared to the baseline
Description
Quantification of serum lactate dehydrogenase in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum aspartate and alanine aminotransferase levels after drinking compared to the baseline
Description
Quantification of serum aspartate and alanine aminotransferase in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
Title
Change in serum gamma glutamyl transferase levels after drinking compared to the baseline
Description
Quantification of serum gamma glutamyl transferase in blood samples
Time Frame
before drinking (at 7 pm), within 30 minutes after 1.5 hour long drinking (at 9 pm) and in the next morning after drinking (at 6 am, 9 hours after drinking)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
medical students, who regularly attend social gatherings where alcohol is consumed and had already experienced the symptoms of hangover.
healthy
not pregnant
without any chronic diseases
not taking any medications.
signed informed consent.
Exclusion Criteria:
drinking after the end of the study
taking any other psychoactive substances or took other measures that supposedly could alleviate the hangover symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miran Brvar, MD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
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N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking
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