Does Mixing Alcoholic Drinks Make Hangover Worse?
Primary Purpose
Alcohol-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mixing alcohol
Single type alcohol
Sponsored by
About this trial
This is an interventional health services research trial for Alcohol-Related Disorders focused on measuring alcohol, hangover
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single type
mixed type
Arm Description
Restricted to drinking only one type of alcohol
Drinking and mixing different types of alcohols freely
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of drinks
Total number of drinks defined as 12 g of alcohol consumed during evening
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.
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.
Full Information
NCT ID
NCT03506516
First Posted
February 12, 2018
Last Updated
April 23, 2018
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03506516
Brief Title
Does Mixing Alcoholic Drinks Make Hangover Worse?
Official Title
Does Mixing Alcoholic Drinks Make Hangover Worse? A Randomized Controlled Trial in a Naturalistic Setting
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 20, 2016 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders
Keywords
alcohol, hangover
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single type
Arm Type
Experimental
Arm Description
Restricted to drinking only one type of alcohol
Arm Title
mixed type
Arm Type
Active Comparator
Arm Description
Drinking and mixing different types of alcohols freely
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixing alcohol
Other Intervention Name(s)
Ethanol
Intervention Description
Alcoholic beverages, different types
Intervention Type
Dietary Supplement
Intervention Name(s)
Single type alcohol
Other Intervention Name(s)
Ethanol
Intervention Description
Alcoholic beverages, different types
Primary Outcome Measure Information:
Title
Acute Hangover Severity Scale (AHSS)
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Number of drinks
Description
Total number of drinks defined as 12 g of alcohol consumed during evening
Time Frame
Baseline
Title
Acute Hangover Severity Scale (AHSS) 2
Description
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.
Time Frame
after 4 hours
Title
Acute Hangover Severity Scale (AHSS) 3
Description
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.
Time Frame
after 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole G Christiansen, MD
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Does Mixing Alcoholic Drinks Make Hangover Worse?
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