Alc-Excr: The Effect of Exercise on Alcohol Craving

Sponsor
Western University, Canada (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05955911
Collaborator
(none)
70
2
16

Study Details

Study Description

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 beverage.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
  • Behavioral: Coloring
N/A

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 beverage and will be allowed to drink as much or as little of the beverages as they would like.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Exercise on Alcohol Craving
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise

Mild-to-moderate treadmill walking (25%-55% of heartrate reserve).

Behavioral: Exercise
20 minutes of mild-to-moderate intensity (25%-55% heartrate reserve) walking on a treadmill.

Other: Coloring

Coloring in an adult coloring book as a distraction activity

Behavioral: Coloring
20 minutes of coloring in adult coloring book

Outcome Measures

Primary Outcome Measures

  1. Changes in alcohol craving after alcohol prime dose [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.

  2. Post-intervention alcohol beverage consumption [Post-intervention (approximately 50 minutes after prime dose consumption)]

    It is expected that individuals in the exercise condition will consume more of the alcohol beverage (milliliters of beverage consumed) than individuals in the coloring condition.

Secondary Outcome Measures

  1. Changes in alcohol wanting after alcohol prime dose [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Western University, Canada

Investigators

  • Principal Investigator: Jesus Chavarria, Ph.D., Western University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jesus Chavarria, Assistant Professor, Western University, Canada
ClinicalTrials.gov Identifier:
NCT05955911
Other Study ID Numbers:
  • 0000055296
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 24, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jesus Chavarria, Assistant Professor, Western University, Canada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2023