Alcohol-Related DisordersNCT03506516
Does Mixing Alcoholic Drinks Make Hangover Worse?
A study testing Mixing alcohol and Single type alcohol in people with Alcohol-Related Disorders, run by Zealand University Hospital.
Trial summary
Does mixing alcohol make hangover worse? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Disorders
- What is being tested?
- Mixing alcohol and Single type alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2016to 31 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written and oral consent
- minimum 18 years old
- participating in Danish Health Research Retreat in Turkey 2016
- will consume alcoholic beverages
Who cannot join
- underage
- will not consume alcoholic beverages
About this study
Official title: Does Mixing Alcoholic Drinks Make Hangover Worse? A Randomized Controlled Trial in a Naturalistic Setting
Does mixing alcohol make hangover worse?
Read the detailed description
Hangover is the most commonly occurring morbidity associated with heavy drinking.
Our aim was to test the hypothesis that mixing alcoholic drinks as compared to drinking one type of alcohol only (beer, wine or spirits) associate with a higher alcohol intake and worse hangover.
- Conditions
- Alcohol-Related Disorders
- Being tested
- Mixing alcohol, Single type alcohol
- Keywords
- alcohol, hangover
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixing alcoholDietary supplement
Also called Ethanol
Alcoholic beverages, different types
Single type alcoholDietary supplement
Also called Ethanol
Alcoholic beverages, different types
| Study group | Role | What they receive |
|---|---|---|
| single type | Experimental | Restricted to drinking only one type of alcohol Receives: Dietary Supplement: Single type alcohol |
| mixed type | Active comparator | Drinking and mixing different types of alcohols freely Receives: Dietary Supplement: Mixing alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Hangover Severity Scale (AHSS)
AHSS is a 12-item alcohol hangover measurement tool recommended for application in hangover research with a predictive validity of 92.4 %, significantly higher than that of other hangover scales (Penning et al., 2012). Alcohol hangover was measured thrice the day after drinking; in the morning immediately after waking up, at midday, and in the afternoon. The individual participant assessed his or her own hangover the day after.
Measured: Baseline
Secondary outcomes (3)
Number of drinks
Total number of drinks defined as 12 g of alcohol consumed during evening
Measured: Baseline
Acute Hangover Severity Scale (AHSS) 2
AHSS is a 12-item alcohol hangover measurement tool recommended for application in hangover research with a predictive validity of 92.4 %, significantly higher than that of other hangover scales (Penning et al., 2012). Alcohol hangover was measured thrice the day after drinking; in the morning immediately after waking up, at midday, and in the afternoon. The individual participant assessed his or her own hangover the day after.
Measured: after 4 hours
Acute Hangover Severity Scale (AHSS) 3
AHSS is a 12-item alcohol hangover measurement tool recommended for application in hangover research with a predictive validity of 92.4 %, significantly higher than that of other hangover scales (Penning et al., 2012). Alcohol hangover was measured thrice the day after drinking; in the morning immediately after waking up, at midday, and in the afternoon. The individual participant assessed his or her own hangover the day after.
Measured: after 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start20 May 2016
- Primary completion30 May 2016
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ole G Christiansen, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506516
- Sponsor's protocol ID
- VEK16028829
- Status last verified
- Apr 2018
- First submitted
- 12 Feb 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mixing Alcoholic Drinks Make Hangover Worse? A Randomized Controlled Trial in a Naturalistic Setting
- ClinicalTrials.gov ID
- NCT03506516
- Acronym / sponsor ID
- VEK16028829
- Conditions
- Alcohol-Related Disorders
- Keywords
- alcohol, hangover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 20 May 2016 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 24 Apr 2018 (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.
Does mixing alcohol make hangover worse?
Detailed description
Hangover is the most commonly occurring morbidity associated with heavy drinking.
Our aim was to test the hypothesis that mixing alcoholic drinks as compared to drinking one type of alcohol only (beer, wine or spirits) associate with a higher alcohol intake and worse hangover.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single type | Experimental | Dietary Supplement: Single type alcoholRestricted to drinking only one type of alcohol |
| mixed type | Active comparator | Dietary Supplement: Mixing alcoholDrinking and mixing different types of alcohols freely |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written and oral consent
- minimum 18 years old
- participating in Danish Health Research Retreat in Turkey 2016
- will consume alcoholic beverages
Key exclusion criteria (2 listed)
- underage
- will not consume alcoholic beverages
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 |
|---|---|---|
| Mixing alcoholAlso: EthanolAlcoholic beverages, different types | Dietary supplement | mixed type |
| Single type alcoholAlso: EthanolAlcoholic beverages, different types | Dietary supplement | single type |
Primary outcome
Acute Hangover Severity Scale (AHSS)
Time frame: Baseline
AHSS is a 12-item alcohol hangover measurement tool recommended for application in hangover research with a predictive validity of 92.4 %, significantly higher than that of other hangover scales (Penning et al., 2012). Alcohol hangover was measured thrice the day after drinking; in the morning immediately after waking up, at midday, and in the afternoon. The individual participant assessed his or her own hangover the day after.
3 secondary outcomes
Number of drinks
Time frame: Baseline
Acute Hangover Severity Scale (AHSS) 2
Time frame: after 4 hours
Acute Hangover Severity Scale (AHSS) 3
Time frame: after 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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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.
Ole G Christiansen, MD principal investigator
Zealand University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mixing alcohol and Single type alcohol in people with Alcohol-Related Disorders, run by Zealand University Hospital.
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 4 inclusion and 2 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute Hangover Severity Scale (AHSS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2018.