Clinical trial NCT05911282: N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking
Official title: N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ethanol Intoxication
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Alcohol Hangover Severity Scale
timeFrame: next morning after drinking (at 6 am; 9 hours after drinking)
measure: Change in acetaldehyde level after drinking compared to the baseline value
timeFrame: 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)
measure: Change in serum oxidative biomarker level after drinking compared to the baseline value
timeFrame: 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 outcomes:
measure: Change in serum ethanol level after drinking compared to the baseline value
timeFrame: 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)
measure: Change in serum sodium levels after drinking compared to the baseline
timeFrame: 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)
measure: Change in serum potassium levels after drinking compared to the baseline
timeFrame: 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)
measure: Change in serum urea levels after drinking compared to the baseline
timeFrame: 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)
measure: Change in serum creatinine levels after drinking compared to the baseline
timeFrame: 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)
measure: Change in serum creatinine kinase levels after drinking compared to the baseline
timeFrame: 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)
measure: Change in serum lactate dehydrogenase levels after drinking compared to the baseline
timeFrame: 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)
measure: Change in serum aspartate and alanine aminotransferase levels after drinking compared to the baseline
timeFrame: 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)
measure: Change in serum gamma glutamyl transferase levels after drinking compared to the baseline
timeFrame: 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)
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Miran Brvar, MD
role: PRINCIPAL_INVESTIGATOR
References: