- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506516
Does Mixing Alcoholic Drinks Make Hangover Worse?
April 23, 2018 updated by: Zealand University Hospital
Does Mixing Alcoholic Drinks Make Hangover Worse? A Randomized Controlled Trial in a Naturalistic Setting
Does mixing alcohol make hangover worse?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- written and oral consent
- minimum 18 years old
- participating in Danish Health Research Retreat in Turkey 2016
- will consume alcoholic beverages
Exclusion Criteria:
- underage
- will not consume alcoholic beverages
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: single type
Restricted to drinking only one type of alcohol
|
Alcoholic beverages, different types
Other Names:
|
ACTIVE_COMPARATOR: mixed type
Drinking and mixing different types of alcohols freely
|
Alcoholic beverages, different types
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of drinks
Time Frame: Baseline
|
Total number of drinks defined as 12 g of alcohol consumed during evening
|
Baseline
|
Acute Hangover Severity Scale (AHSS) 2
Time Frame: after 4 hours
|
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.
|
after 4 hours
|
Acute Hangover Severity Scale (AHSS) 3
Time Frame: after 8 hours
|
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.
|
after 8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ole G Christiansen, MD, Zealand University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 20, 2016
Primary Completion (ACTUAL)
May 30, 2016
Study Completion (ACTUAL)
January 31, 2018
Study Registration Dates
First Submitted
February 12, 2018
First Submitted That Met QC Criteria
April 23, 2018
First Posted (ACTUAL)
April 24, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 24, 2018
Last Update Submitted That Met QC Criteria
April 23, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEK16028829
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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