Trial Outcomes & Findings for Use of NAC in Alleviation of Hangover Symptoms (NCT NCT02541422)

Last Updated: 2018-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

12 hours or less

Results posted on

2018-05-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
First Intervention STARTED	23	26
First Intervention COMPLETED	23	26
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	23	26
Second Intervention COMPLETED	23	26
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=49 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.
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=49 Participants
Age, Categorical >=65 years	0 Participants n=49 Participants
Sex: Female, Male Female	18 Participants n=49 Participants
Sex: Female, Male Male	31 Participants n=49 Participants
Region of Enrollment United States	49 participants n=49 Participants

PRIMARY outcome

Timeframe: 12 hours or less

Outcome measures

Outcome measures
Measure	NAC Group n=49 Participants Patients receiving NAC after drinking to breathalyzer value 0.1 N Acetyl Cysteine	Placebo Group n=49 Participants Patients receiving placebo after drinking to breathalyzer value 0.1 placebo
Hangover Symptom Scale total Hangover symptom score	10 units on a scale Interval 0.0 to 35.0	13 units on a scale Interval 0.0 to 38.0
Hangover Symptom Scale headache	1 units on a scale Interval 0.0 to 4.0	1 units on a scale Interval 0.0 to 4.0
Hangover Symptom Scale nauseated	0 units on a scale Interval 0.0 to 4.0	1 units on a scale Interval 0.0 to 4.0
Hangover Symptom Scale feeling weak	1 units on a scale Interval 0.0 to 4.0	1 units on a scale Interval 0.0 to 4.0

Adverse Events

NAC Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NAC Group n=49 participants at risk Patients receiving NAC after drinking to breathalyzer value 0.1 N Acetyl Cysteine	Placebo Group n=49 participants at risk Patients receiving placebo after drinking to breathalyzer value 0.1 placebo
Gastrointestinal disorders gas	6.1% 3/49 • 20 hours	0.00% 0/49 • 20 hours
Nervous system disorders insomnia	2.0% 1/49 • 20 hours	0.00% 0/49 • 20 hours
Gastrointestinal disorders bloating	2.0% 1/49 • 20 hours	0.00% 0/49 • 20 hours
Gastrointestinal disorders acid reflux	2.0% 1/49 • 20 hours	0.00% 0/49 • 20 hours
Musculoskeletal and connective tissue disorders muscle twitches	2.0% 1/49 • 20 hours	0.00% 0/49 • 20 hours
Gastrointestinal disorders stomach pain	2.0% 1/49 • 20 hours	0.00% 0/49 • 20 hours
Gastrointestinal disorders diarrhea	2.0% 1/49 • 20 hours	0.00% 0/49 • 20 hours
Nervous system disorders headache	2.0% 1/49 • 20 hours	6.1% 3/49 • 20 hours
Skin and subcutaneous tissue disorders rash	2.0% 1/49 • 20 hours	0.00% 0/49 • 20 hours
Gastrointestinal disorders vomiting	0.00% 0/49 • 20 hours	2.0% 1/49 • 20 hours

Additional Information

Holly Stankewicz, D.O.

St. Luke's University Health Network

Phone: 610-360-2725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place