N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking

NCT ID: NCT05911282

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-06-30

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).

Conditions

Ethanol Intoxication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

NAC

NAC group was given 1.2 g of N-acetylcysteine before and 1.2 g after drinking alcohol

Group Type: EXPERIMENTAL

N Acetylcysteine

Intervention Type: DRUG

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.

PLACEBO

Placebo group was given lemon juice before and after drinking alcohol

Group Type: PLACEBO_COMPARATOR

Lemon juice

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

NAC; placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Miran Brvar

Head of Centre for Clinical Toxicology and Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miran Brvar, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

20200175

Identifier Type: -

Identifier Source: org_study_id