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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05955911
Other study ID # 0000055296
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Western University, Canada
Contact Jeus Chavarria, Ph.D.
Phone 519-661-2111
Email jchavarr@uwo.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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; 2) compared to a distraction, will mild-to-moderate intensity exercise reduce the amount of consumption of an alcohol-placebo beverage.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
20 minutes of Moderate intensity (40%-59% heartrate reserve) walking on a treadmill.
Coloring
20 minutes of coloring in adult coloring book

Locations

Country Name City State
Canada Western University London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
Primary 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. Post-intervention (approximately 50 minutes after prime dose consumption)
Secondary 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. mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
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