N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking

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.

Study Overview

• Status: Completed
• Conditions: Ethanol Intoxication
• Intervention / Treatment: Drug: N Acetylcysteine; Other: Lemon juice

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAC; NAC group was given 1.2 g of N-acetylcysteine before and 1.2 g after drinking alcohol	Drug: N Acetylcysteine; 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.; Other Names: NAC
Placebo Comparator: PLACEBO; Placebo group was given lemon juice before and after drinking alcohol	Other: Lemon juice; 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.; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	next morning after drinking (at 6 am; 9 hours after drinking)
Change in acetaldehyde level after drinking compared to the baseline value	Quantification of acetaldehyde in blood samples	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)
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	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 Measures

Outcome Measure	Measure Description	Time Frame
Change in serum ethanol level after drinking compared to the baseline value	Quantification of ethanol in blood samples	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)
Change in serum sodium levels after drinking compared to the baseline	Quantification of serum sodium in blood samples	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)
Change in serum potassium levels after drinking compared to the baseline	Quantification of serum potassium in blood samples	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)
Change in serum urea levels after drinking compared to the baseline	Quantification of serum urea in blood samples	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)
Change in serum creatinine levels after drinking compared to the baseline	Quantification of serum creatinine in blood samples	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)
Change in serum creatinine kinase levels after drinking compared to the baseline	Quantification of serum creatinine kinase in blood samples	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)
Change in serum lactate dehydrogenase levels after drinking compared to the baseline	Quantification of serum lactate dehydrogenase in blood samples	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)
Change in serum aspartate and alanine aminotransferase levels after drinking compared to the baseline	Quantification of serum aspartate and alanine aminotransferase in blood samples	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)
Change in serum gamma glutamyl transferase levels after drinking compared to the baseline	Quantification of serum gamma glutamyl transferase in blood samples	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)

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Principal Investigator: Miran Brvar, MD, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: 20200175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No