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Alcohol & Exercise Study (Alc-Excr)

Primary Purpose

Alcohol-Related Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Coloring
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring Alcohol, Exercise, Heavy Drinkers, Alcohol Craving

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Heavy social alcohol drinkers (i.e., alcohol drinkers who consume 10-40 standard alcohol beverages per week and participate in 1-5 binge drinking episodes [consume 4+/5+ drinks in a sitting for women/men, respectively]) per week. Exclusion Criteria: Meets DSM-5 diagnostic criteria for a current moderate or severe alcohol use disorder Meets DSM-5 diagnostic criteria for a current cannabis use disorder Endorses daily smoking of tobacco Endorses having a current DSM-5 psychiatric disorder Endorses having any medical conditions that may interfere with the exercise condition (e.g., knee-replacement, sprained ankle, etc.) Has a current level of physical activity that exceeds 20 minutes of moderate-to-vigorous physical activity per day Endorses illicit substance use (i.e., use of illicit substances x>2 times in the past year) Has self-reported allergies to pineapple juice, cranberry juice, orange juice, &/or tonic water Individuals not proficient in reading, writing, or speaking in English Women who are trying to conceive or who are pregnant Women who are currently breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Exercise

    Coloring

    Arm Description

    Moderate intensity treadmill walking (40%-59% of heartrate reserve).

    Coloring in an adult coloring book as a distraction activity

    Outcomes

    Primary Outcome Measures

    Changes in alcohol craving after alcohol prime dose
    It is expected that the exercise condition will lead to larger reductions in alcohol craving (Alcohol Urge Questionnaire) at the mid- and post-intervention time points as compared to the coloring condition.
    Post-intervention alcohol beverage consumption
    It is expected that individuals in the exercise condition will consume more of the alcohol-placebo beverage (milliliters of beverage consumed) than individuals in the coloring condition.

    Secondary Outcome Measures

    Changes in alcohol wanting after alcohol prime dose
    It is expected that the exercise condition will lead to larger reductions in alcohol wanting (Drug Effects Questionnaire: Want More item) at the mid- and post-intervention time points as compared to the coloring condition.

    Full Information

    First Posted
    July 13, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Western University, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05955911
    Brief Title
    Alcohol & Exercise Study
    Acronym
    Alc-Excr
    Official Title
    The Effect of an Acute Exercise Intervention on Alcohol Craving and Alcohol Seeking Behaviors Among Heavy Social Drinkers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western University, Canada

    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
    The goal of this clinical trial is to learn if exercise can reduce alcohol craving in heavy social alcohol drinkers. The main questions this project aims to answer are 1) compared to a distraction activity (i.e., coloring), will mild-to-moderate intensity exercise (i.e., walking on a treadmill) reduce alcohol craving; 2) compared to a distraction, will mild-to-moderate intensity exercise reduce the amount of consumption of an alcohol-placebo beverage.
    Detailed Description
    Upon arriving to the study, participants will complete baseline measures assessing for the inclusion and exclusion criteria, as well as baseline alcohol craving and subjective response measures. Participants will then be randomly assigned into the active treatment (exercise) or distraction (coloring) condition. After randomization, participants will consume a low-dose alcohol beverage (BAC=0.03g/dL; equivalent to approximately 1 standard alcohol beverage) within five minutes to induce active alcohol craving. 15 minutes post-beverage consumption, participants will complete the alcohol craving and subjective response measures. At 20 minutes post-beverage consumption, participants will begin their randomly assigned 20-minute activity (exercise or coloring). At approximately 12 minutes into the activity (32 minutes post beverage consumption) and immediately after the activity (44 minutes post beverage consumption), the participants will complete the alcohol craving and subjective response measures. Participants will then be given a tray of three 8oz. cups of water and 3 8oz. cups of an alcohol-placebo beverage and will be allowed to drink as much or as little of the beverages as they would like.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol-Related Disorders
    Keywords
    Alcohol, Exercise, Heavy Drinkers, Alcohol Craving

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Description
    Moderate intensity treadmill walking (40%-59% of heartrate reserve).
    Arm Title
    Coloring
    Arm Type
    Other
    Arm Description
    Coloring in an adult coloring book as a distraction activity
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    20 minutes of Moderate intensity (40%-59% heartrate reserve) walking on a treadmill.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Coloring
    Intervention Description
    20 minutes of coloring in adult coloring book
    Primary Outcome Measure Information:
    Title
    Changes in alcohol craving after alcohol prime dose
    Description
    It is expected that the exercise condition will lead to larger reductions in alcohol craving (Alcohol Urge Questionnaire) at the mid- and post-intervention time points as compared to the coloring condition.
    Time Frame
    mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
    Title
    Post-intervention alcohol beverage consumption
    Description
    It is expected that individuals in the exercise condition will consume more of the alcohol-placebo beverage (milliliters of beverage consumed) than individuals in the coloring condition.
    Time Frame
    Post-intervention (approximately 50 minutes after prime dose consumption)
    Secondary Outcome Measure Information:
    Title
    Changes in alcohol wanting after alcohol prime dose
    Description
    It is expected that the exercise condition will lead to larger reductions in alcohol wanting (Drug Effects Questionnaire: Want More item) at the mid- and post-intervention time points as compared to the coloring condition.
    Time Frame
    mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Heavy social alcohol drinkers (i.e., alcohol drinkers who consume 10-40 standard alcohol beverages per week and participate in 1-5 binge drinking episodes [consume 4+/5+ drinks in a sitting for women/men, respectively]) per week. Exclusion Criteria: Meets DSM-5 diagnostic criteria for a current moderate or severe alcohol use disorder Meets DSM-5 diagnostic criteria for a current cannabis use disorder Endorses daily smoking of tobacco Endorses having a current DSM-5 psychiatric disorder Endorses having any medical conditions that may interfere with the exercise condition (e.g., knee-replacement, sprained ankle, etc.) Has a current level of physical activity that exceeds 20 minutes of moderate-to-vigorous physical activity per day Endorses illicit substance use (i.e., use of illicit substances x>2 times in the past year) Has self-reported allergies to pineapple juice, cranberry juice, orange juice, &/or tonic water Individuals not proficient in reading, writing, or speaking in English Women who are trying to conceive or who are pregnant Women who are currently breastfeeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeus Chavarria, Ph.D.
    Phone
    519-661-2111
    Ext
    81332
    Email
    jchavarr@uwo.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Harry Prapavessis, Ph.D.
    Phone
    519-661-2111
    Ext
    80173
    Email
    hprapave@uwo.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesus Chavarria, Ph.D.
    Organizational Affiliation
    Western University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Alcohol & Exercise Study

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