Alcohol & Exercise Study

Alcohol-Related Disorders Clinical Trial

— Alc-Excr  

Official title:

The Effect of an Acute Exercise Intervention on Alcohol Craving and Alcohol Seeking Behaviors Among Heavy Social Drinkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955911
• Other study ID #: 0000055296
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alcohol-Related Disorders

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)