Clinical trial NCT05955911: Alcohol & Exercise Study
Official title: The Effect of an Acute Exercise Intervention on Alcohol Craving and Alcohol Seeking Behaviors Among Heavy Social Drinkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol-Related Disorders
Keywords: Alcohol
Exercise
Heavy Drinkers
Alcohol Craving
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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\&gt;2 times in the past year)
* Has self-reported allergies to pineapple juice, cranberry juice, orange juice, \&amp;/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

Primary outcomes:
measure: Changes in alcohol craving after alcohol prime dose
timeFrame: mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
measure: Post-intervention alcohol beverage consumption
timeFrame: Post-intervention (approximately 50 minutes after prime dose consumption)
Secondary outcomes:
measure: Changes in alcohol wanting after alcohol prime dose
timeFrame: mid-intervention (32 minutes after prime dose consumption) & post-intervention (44 minutes after prime dose consumption)
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Jesus Chavarria, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: