Alcohol-Related DisordersAlc-ExcrNCT05955911
Alcohol & Exercise Study
A study testing Exercise and Coloring in people with Alcohol-Related Disorders, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Alcohol-Related Disorders
- What is being tested?
- Exercise and Coloring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2023to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol-Related Disorders
- Being tested
- Exercise, Coloring
- Keywords
- Alcohol, Exercise, Heavy Drinkers, Alcohol Craving
- Medical subject headings
- Alcohol-Related Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
20 minutes of Moderate intensity (40%-59% heartrate reserve) walking on a treadmill.
ColoringBehavioural
20 minutes of coloring in adult coloring book
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Moderate intensity treadmill walking (40%-59% of heartrate reserve). Receives: Behavioral: Exercise |
| Coloring | Other | Coloring in an adult coloring book as a distraction activity Receives: Behavioral: Coloring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
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.
Measured: Post-intervention (approximately 50 minutes after prime dose consumption)
Secondary outcomes (1)
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.
Measured: mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Dec 2023
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Chavarria, Western University, Canada
- Investigators
- Jesus Chavarria, Ph.D., Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955911
- Sponsor's protocol ID
- 0000055296
- Acronym
- Alc-Excr
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Acute Exercise Intervention on Alcohol Craving and Alcohol Seeking Behaviors Among Heavy Social Drinkers
- ClinicalTrials.gov ID
- NCT05955911
- Acronym / sponsor ID
- Alc-Excr / 0000055296
- Conditions
- Alcohol-Related Disorders
- Keywords
- Alcohol, Exercise, Heavy Drinkers, Alcohol Craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseModerate intensity treadmill walking (40%-59% of heartrate reserve). |
| Coloring | Other | Behavioral: ColoringColoring in an adult coloring book as a distraction activity |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise20 minutes of Moderate intensity (40%-59% heartrate reserve) walking on a treadmill. | Behavioural | Exercise |
| Coloring20 minutes of coloring in adult coloring book | Behavioural | Coloring |
Primary outcome
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.
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Chavarria, Ph.D. principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Coloring in people with Alcohol-Related Disorders, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.