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N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking

U

University Medical Centre Ljubljana

Status

Completed

Conditions

Ethanol Intoxication

Treatments

Drug: N Acetylcysteine
Other: Lemon juice

Study type

Interventional

Funder types

Other

Identifiers

NCT05911282
20200175

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups, including a placebo group

NAC
Experimental group
Description:
NAC group was given 1.2 g of N-acetylcysteine before and 1.2 g after drinking alcohol
Treatment:
Drug: N Acetylcysteine
PLACEBO
Placebo Comparator group
Description:
Placebo group was given lemon juice before and after drinking alcohol
Treatment:
Other: Lemon juice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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