- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955911
Alcohol & Exercise Study (Alc-Excr)
July 18, 2025 updated by: Jesus Chavarria, Western University, Canada
The Effect of an Acute Exercise Intervention on Alcohol Craving and Alcohol Seeking Behaviors Among Heavy Social Drinkers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Western University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Moderate or Severe 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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Coloring
Coloring in an adult coloring book as a distraction activity
|
20 minutes of coloring in adult coloring book
|
|
Experimental: Exercise
Moderate intensity treadmill walking (40%-59% of heartrate reserve).
|
20 minutes of Moderate intensity (40%-59% heartrate reserve) walking on a treadmill.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in alcohol craving after alcohol prime dose
Time Frame: mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
|
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.
|
mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
|
|
Post-intervention alcohol beverage consumption
Time Frame: Post-intervention (approximately 50 minutes after prime dose 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.
|
Post-intervention (approximately 50 minutes after prime dose consumption)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in alcohol wanting after alcohol prime dose
Time Frame: mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
|
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.
|
mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jesus Chavarria, Ph.D., Western University
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)
December 1, 2023
Primary Completion (Actual)
July 14, 2025
Study Completion (Actual)
July 14, 2025
Study Registration Dates
First Submitted
July 13, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 21, 2023
Study Record Updates
Last Update Posted (Actual)
July 20, 2025
Last Update Submitted That Met QC Criteria
July 18, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000055296
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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