Prevention of Hangover Using N-Acety CysteineNCT03104959
Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
A study testing N-acetyl cysteine in people with Prevention of Hangover Using N-Acety Cysteine, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
Trial summary
This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. Consent is obtained prior to participation in the study while the participant is sober. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of Hangover Using N-Acety Cysteine
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 6 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age over 21 years
- able and agrees to drink alcohol
Who cannot join
- alcoholism (self-reported)
- pregnancy
- reactive airway disease
- diabetes
- kidney/bladder stones
- kidney disease
Show all 12Show fewer
- liver disease
- stomach ulcer
- organ transplant patients
- dialysis patients
- allergies to alcohol, eggs, milk, or wheat
- volunteers taking the following medications: opiate pain medication, activated charcoal, ampicillin,carbamazepine, cephalosporidine, methicillin, nitroglycerine, oxacillin, penicillin G, quinicillin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. Consent is obtained prior to participation in the study while the participant is sober. Volunteers are recruited from residency programs, hospital employees, emergency medical personnel, and friends of the study investigators. If the volunteers choose to drink, they can participate in the study the night of ingestion of alcohol. There is no amount we ask them to drink, and we allow them to withdraw from the study at any time. We never force them to drink alcohol, or even encourage it. The participation is completely voluntary, if they would like to participate and if they choose to drink alcohol, we ask them to participate in the placebo controlled study in the safety of their own home. Then materials for the study are given out prior to their participation. An envelope is given with the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participant fills out a Hangover Symptom Score questionnaire . A random number generator is used to determine placebo or NAC first, then the participant is given the other treatment at their subsequent encounter. Then study is being conducted over a series of many months, and data can be analyzed by the hangover symptoms 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.
- Being tested
- N-acetyl cysteine, placebo
- Keywords
- hangovers, N-acetyl cysteine, alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDietary supplement
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Healthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take placebo capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning Receives: Other: placebo |
| N-acetyl cysteine | Experimental | Healthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take N-Acetyl Cysteine capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning Receives: Dietary Supplement: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo
Measured: less than 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startJan 2016
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
Why it stopped: unable to enroll sufficient number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prevention of Hangover Using N-Acety CysteineStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104959
- Sponsor's protocol ID
- SLUHN2015-105
- Status last verified
- Jun 2018
- First submitted
- 12 Dec 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lieber CS. Relationships between nutrition, alcohol use, and liver disease. Alcohol Res Health. 2003;27(3):220-31.
PubMed 15535450Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60.
PubMed 15706734Gyamfi MA, Wan YJ. Pathogenesis of alcoholic liver disease: the role of nuclear receptors. Exp Biol Med (Maywood). 2010 May;235(5):547-60. doi: 10.1258/ebm.2009.009249.
PubMed 20463294
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
- ClinicalTrials.gov ID
- NCT03104959
- Acronym / sponsor ID
- SLUHN2015-105
- Keywords
- hangovers, N-acetyl cysteine, alcohol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to enroll sufficient number of participants
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Luke's Hospital and Health Network, PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. Consent is obtained prior to participation in the study while the participant is sober. Volunteers are recruited from residency programs, hospital employees, emergency medical personnel, and friends of the study investigators. If the volunteers choose to drink, they can participate in the study the night of ingestion of alcohol. There is no amount we ask them to drink, and we allow them to withdraw from the study at any time. We never force them to drink alcohol, or even encourage it. The participation is completely voluntary, if they would like to participate and if they choose to drink alcohol, we ask them to participate in the placebo controlled study in the safety of their own home. Then materials for the study are given out prior to their participation. An envelope is given with the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participant fills out a Hangover Symptom Score questionnaire . A random number generator is used to determine placebo or NAC first, then the participant is given the other treatment at their subsequent encounter. Then study is being conducted over a series of many months, and data can be analyzed by the hangover symptoms 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
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboHealthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take placebo capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning |
| N-acetyl cysteine | Experimental | Dietary Supplement: N-acetyl cysteineHealthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take N-Acetyl Cysteine capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 21 years
- able and agrees to drink alcohol
Key exclusion criteria (12 listed)
- alcoholism (self-reported)
- pregnancy
- reactive airway disease
- diabetes
- kidney/bladder stones
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 cysteine | Dietary supplement | N-acetyl cysteine |
| placebo | Other | Placebo |
Primary outcome
Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo
Time frame: less than 24 hours
Results and safety
The study was stopped early (reason given: unable to enroll sufficient number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Background: PubMed 15535450Lieber CS. Relationships between nutrition, alcohol use, and liver disease. Alcohol Res Health. 2003;27(3):220-31.
- Background: PubMed 15706734Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60.
- Background: PubMed 20463294Gyamfi MA, Wan YJ. Pathogenesis of alcoholic liver disease: the role of nuclear receptors. Exp Biol Med (Maywood). 2010 May;235(5):547-60. doi: 10.1258/ebm.2009.009249.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prevention of Hangover Using N-Acety Cysteine, 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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 11 Jun 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?
The study was stopped early (reason given: unable to enroll sufficient number of participants). Results are not available in the source record.
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?
Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo (time frame: less than 24 hours). 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 NCT03104959, which also lists 3 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 11 Jun 2018.