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Use of NAC in Alleviation of Hangover Symptoms

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ClinicalTrials.gov Identifier: NCT02541422
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Hangover Symptoms, NAC
Interventions Dietary Supplement: N Acetyl Cysteine
Other: placebo
Enrollment 62
Recruitment Details  
Pre-assignment Details 62 people were enrolled however only 49 were included in the analysis due to not submitting their surveys or did not complete the first day of the study.
Arm/Group Title NAC First, Then Placebo Placebo First Then NAC Group
Hide Arm/Group Description Patients receiving NAC after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received placebo then again completed the survey in the morning Patients receiving placebo after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received NAC then again completed the survey in the morning
Period Title: First Intervention
Started 23 26
Completed 23 26
Not Completed 0 0
Period Title: Second Intervention
Started 23 26
Completed 23 26
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants received the 2 interventions - NAC and placebo. The participants completed one intervention on one day and returned to complete the other intervention on a subsequent day.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
<=18 years
0
   0.0%
Between 18 and 65 years
49
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
18
  36.7%
Male
31
  63.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants
49
1.Primary Outcome
Title Hangover Symptom Scale
Hide Description In the morning, each participate will fill out a Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 – 4 point Hangover Symptom Severity scale. 0 representing "strongly disagree" or "feels like I did not drink last night" to 4 representing "strongly agree" or "I'm so hungover / I'm never drinking again" for each symptom. The symptoms on the Hangover Symptom Scale are: feeling thirsty or dehydrated, feeling more tired than usual, headache, nauseated, vomited, feeling weak, difficulty concentrating, more sensitive to light and sound than usual, sweating more than usual, had trouble sleeping, feeling anxious, feeling depressed, experienced trembling or shaking. The total score could range from 0-52 with 0 being no symptoms of hangover and 52 being the worst symptoms of hangover. This study looked specifically at the overall hangover score, nauseated, feeling weak and headache.
Time Frame 12 hours or less
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAC Group Placebo Group
Hide Arm/Group Description:

Patients receiving NAC after drinking to breathalyzer value 0.1

N Acetyl Cysteine

Patients receiving placebo after drinking to breathalyzer value 0.1

placebo

Overall Number of Participants Analyzed 49 49
Median (Full Range)
Unit of Measure: units on a scale
total Hangover symptom score
10
(0 to 35)
13
(0 to 38)
headache
1
(0 to 4)
1
(0 to 4)
nauseated
0
(0 to 4)
1
(0 to 4)
feeling weak
1
(0 to 4)
1
(0 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAC Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments p-value calculated for the total hangover scale
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAC Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments p value calculated for symptom of headache
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NAC Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments p value calculated for symptom of nausea
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NAC Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments p value calculated for symptom of weakness
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 20 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NAC Group Placebo Group
Hide Arm/Group Description

Patients receiving NAC after drinking to breathalyzer value 0.1

N Acetyl Cysteine

Patients receiving placebo after drinking to breathalyzer value 0.1

placebo

All-Cause Mortality
NAC Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/49 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
NAC Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NAC Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   11/49 (22.45%)   4/49 (8.16%) 
Gastrointestinal disorders     
gas   3/49 (6.12%)  0/49 (0.00%) 
bloating   1/49 (2.04%)  0/49 (0.00%) 
acid reflux   1/49 (2.04%)  0/49 (0.00%) 
stomach pain   1/49 (2.04%)  0/49 (0.00%) 
diarrhea   1/49 (2.04%)  0/49 (0.00%) 
vomiting   0/49 (0.00%)  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders     
muscle twitches   1/49 (2.04%)  0/49 (0.00%) 
Nervous system disorders     
insomnia   1/49 (2.04%)  0/49 (0.00%) 
headache   1/49 (2.04%)  3/49 (6.12%) 
Skin and subcutaneous tissue disorders     
rash   1/49 (2.04%)  0/49 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Holly Stankewicz, D.O.
Organization: St. Luke's University Health Network
Phone: 610-360-2725
Responsible Party: Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT02541422     History of Changes
Other Study ID Numbers: SLHN 2015-27
First Submitted: September 1, 2015
First Posted: September 4, 2015
Results First Submitted: July 1, 2017
Results First Posted: May 30, 2018
Last Update Posted: May 30, 2018