NCT05955911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

July 13, 2023

Last Update Submit

July 18, 2025

Conditions

Keywords

AlcoholExerciseHeavy DrinkersAlcohol Craving

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (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)

Study Arms (2)

Exercise

EXPERIMENTAL

Moderate intensity treadmill walking (40%-59% of heartrate reserve).

Behavioral: Exercise

Coloring

OTHER

Coloring in an adult coloring book as a distraction activity

Behavioral: Coloring

Interventions

ExerciseBEHAVIORAL

20 minutes of Moderate intensity (40%-59% heartrate reserve) walking on a treadmill.

Exercise
ColoringBEHAVIORAL

20 minutes of coloring in adult coloring book

Coloring

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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\>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Alcohol-Related DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jesus Chavarria, Ph.D.

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

December 1, 2023

Primary Completion

July 14, 2025

Study Completion

July 14, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations