N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking

NCT05911282 | Completed

• 1 other identifier: 20200175
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ethanol Intoxication

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Change in serum ethanol level after drinking compared to the baseline value

  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

  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

  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

  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

  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)

Study Arms (2)

NAC

EXPERIMENTAL

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

Drug: N Acetylcysteine

PLACEBO

PLACEBO COMPARATOR

Placebo group was given lemon juice before and after drinking alcohol

Other: Lemon juice

Interventions

N Acetylcysteine 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.

Also known as: NAC

NAC

Lemon juice 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.

Also known as: placebo

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• drinking after the end of the study
• taking any other psychoactive substances or took other measures that supposedly could alleviate the hangover symptoms

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Miran Brvar, MD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Centre for Clinical Toxicology and Pharmacology

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 22, 2023
• Study Start: June 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)