Hangover Symptoms, NACNCT02541422
Use of NAC in Alleviation of Hangover Symptoms
A study testing N Acetyl Cysteine in people with Hangover Symptoms, NAC, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
Trial summary
This will be a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21 to consume beer on hospital property in a safe environment to ensure immediate availability to medical attention and to security if needed. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hangover Symptoms, NAC
- What is being tested?
- N Acetyl Cysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers over age 21 years
Who cannot join
- Volunteers will be excluded from the study if they suffer from any of the following conditions:
- Alcoholism,
- Pregnancy,
- Reactive Airway Disease,
- Diabetes,
- Kidney or bladder stones,
Show all 23Show fewer
- Kidney disease,
- Liver disease,
- Stomach ulcer,
- Organ transplant patients,
- Dialysis patients,
- and patients with alcohol, egg, milk or wheat allergies.
- Volunteers taking the following medications will not be able to participate:
- activated charcoal,
- ampicillin,
- carbamazepine,
- cephaloridine,
- cloxacillin,
- methicillin,
- nitroglycerine,
- oxacillin,
- penicillin G,
- or quinacillin.
Trial locations and contacts
1 site in 1 country.
About this study
This will be a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21 to consume beer on hospital property in a safe environment to ensure immediate availability to medical attention and to security if needed. Volunteers will be recruited from residency programs, hospital employees, emergency medical personnel, and friends of study investigators. The volunteers will drink to a BAC of 0.1 as checked with a breathalyzer. They will wear a tag around their neck with their study number, which will be hole-punched with every beer consumed, which will be collected at the end of the night for an accurate count of beers consumed per person. They however will not be forced to drink anymore if they are uncomfortable with the amount of alcohol they are consuming and can withdraw from the study at any time. All participants will be required to be driven home by a sober driver once the participant's BAT is 0.02 or less. At the end of the night, the volunteer will be breathalyzed to determine BAC, and given 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. 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. A random number generator will be used to determine Placebo or NAC first, then the participant will be given the other treatment at their subsequent encounter. The study will be conducted over the series of many months, and data can be analyzed by self-control comparing the participant's hangover symptom severity as determined by the hangover symptom scale data when using NAC compared to placebo. The data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.
- Conditions
- Hangover Symptoms, NAC
- Being tested
- N Acetyl Cysteine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N Acetyl CysteineDietary supplement
Also called NAC
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| NAC group | Active comparator | Patients receiving NAC after drinking to breathalyzer value 0.1 Receives: Dietary Supplement: N Acetyl Cysteine |
| Placebo group | Placebo comparator | Patients receiving placebo after drinking to breathalyzer value 0.1 Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hangover Symptom Scale
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.
Measured: 12 hours or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hangover Symptoms, NACStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania
- Investigators
- Holly A Stankewicz, D.O., Principal investigator, St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541422
- Sponsor's protocol ID
- SLHN 2015-27
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2015
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60.
PubMed 15706734Pittler MH, Verster JC, Ernst E. Interventions for preventing or treating alcohol hangover: systematic review of randomised controlled trials. BMJ. 2005 Dec 24;331(7531):1515-8. doi: 10.1136/bmj.331.7531.1515.
PubMed 16373736Wiese JG, Shlipak MG, Browner WS. The alcohol hangover. Ann Intern Med. 2000 Jun 6;132(11):897-902. doi: 10.7326/0003-4819-132-11-200006060-00008.
PubMed 10836917Slutske WS, Piasecki TM, Hunt-Carter EE. Development and initial validation of the Hangover Symptoms Scale: prevalence and correlates of Hangover Symptoms in college students. Alcohol Clin Exp Res. 2003 Sep;27(9):1442-50. doi: 10.1097/01.ALC.0000085585.81711.AE.
PubMed 14506405
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NAC in Alleviation of Hangover Symptoms
- ClinicalTrials.gov ID
- NCT02541422
- Acronym / sponsor ID
- SLHN 2015-27
- Conditions
- Hangover Symptoms, NAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- St. Luke's Hospital and Health Network, PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Posted 30 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21 to consume beer on hospital property in a safe environment to ensure immediate availability to medical attention and to security if needed. Volunteers will be recruited from residency programs, hospital employees, emergency medical personnel, and friends of study investigators. The volunteers will drink to a BAC of 0.1 as checked with a breathalyzer. They will wear a tag around their neck with their study number, which will be hole-punched with every beer consumed, which will be collected at the end of the night for an accurate count of beers consumed per person. They however will not be forced to drink anymore if they are uncomfortable with the amount of alcohol they are consuming and can withdraw from the study at any time. All participants will be required to be driven home by a sober driver once the participant's BAT is 0.02 or less. At the end of the night, the volunteer will be breathalyzed to determine BAC, and given 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. 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. A random number generator will be used to determine Placebo or NAC first, then the participant will be given the other treatment at their subsequent encounter. The study will be conducted over the series of many months, and data can be analyzed by self-control comparing the participant's hangover symptom severity as determined by the hangover symptom scale data when using NAC compared to placebo. The data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC group | Active comparator | Dietary Supplement: N Acetyl CysteinePatients receiving NAC after drinking to breathalyzer value 0.1 |
| Placebo group | Placebo comparator | Other: placeboPatients receiving placebo after drinking to breathalyzer value 0.1 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers over age 21 years
Key exclusion criteria (23 listed)
- Volunteers will be excluded from the study if they suffer from any of the following conditions:
- Alcoholism,
- Pregnancy,
- Reactive Airway Disease,
- Diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N Acetyl CysteineAlso: NAC | Dietary supplement | NAC group |
| placebo | Other | Placebo group |
Primary outcome
Hangover Symptom Scale
Time frame: 12 hours or less
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15706734Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60.
- Results publication: PubMed 16373736Pittler MH, Verster JC, Ernst E. Interventions for preventing or treating alcohol hangover: systematic review of randomised controlled trials. BMJ. 2005 Dec 24;331(7531):1515-8. doi: 10.1136/bmj.331.7531.1515.
- Results publication: PubMed 10836917Wiese JG, Shlipak MG, Browner WS. The alcohol hangover. Ann Intern Med. 2000 Jun 6;132(11):897-902. doi: 10.7326/0003-4819-132-11-200006060-00008.
- Results publication: PubMed 14506405Slutske WS, Piasecki TM, Hunt-Carter EE. Development and initial validation of the Hangover Symptoms Scale: prevalence and correlates of Hangover Symptoms in college students. Alcohol Clin Exp Res. 2003 Sep;27(9):1442-50. doi: 10.1097/01.ALC.0000085585.81711.AE.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly A Stankewicz, D.O. principal investigator
St. Luke's Hospital and Health Network, Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N Acetyl Cysteine in people with Hangover Symptoms, NAC, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hangover Symptom Scale (time frame: 12 hours or less). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02541422, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.