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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
NAC First, Then Placebo 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
Placebo First Then NAC Group 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

Participant Flow for 2 periods

Period 1:   First Intervention
    NAC First, Then Placebo   Placebo First Then NAC Group
STARTED   23   26 
COMPLETED   23   26 
NOT COMPLETED   0   0 

Period 2:   Second Intervention
    NAC First, Then Placebo   Placebo First Then NAC Group
STARTED   23   26 
COMPLETED   23   26 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants 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.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   49 
<=18 years      0   0.0% 
Between 18 and 65 years      49 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   49 
Female      18  36.7% 
Male      31  63.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   49 
United States   49 


  Outcome Measures

1.  Primary:   Hangover Symptom Scale   [ Time Frame: 12 hours or less ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Hangover Symptom Scale
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NAC Group

Patients receiving NAC after drinking to breathalyzer value 0.1

N Acetyl Cysteine

Placebo Group

Patients receiving placebo after drinking to breathalyzer value 0.1

placebo


Measured Values
   NAC Group   Placebo Group 
Participants Analyzed   49   49 
Hangover Symptom Scale 
[Units: Units on a scale]
Median (Full Range)
   
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) 


Statistical Analysis 1 for Hangover Symptom Scale
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.45
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value calculated for the total hangover scale

Statistical Analysis 2 for Hangover Symptom Scale
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.93
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p value calculated for symptom of headache

Statistical Analysis 3 for Hangover Symptom Scale
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.11
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p value calculated for symptom of nausea

Statistical Analysis 4 for Hangover Symptom Scale
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.72
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p value calculated for symptom of weakness




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: holly.stankewicz@gmail.com


Publications of Results:

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