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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
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol-Related Disorders focused on measuring alcohol, hangover

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 12, 2018
    Last Updated
    April 23, 2018
    Sponsor
    Zealand University Hospital
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    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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