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Clinical Trials/NCT06317753
NCT06317753Not yet recruitingNot Applicable

Can Exercise Rewire the Brain Addiction Circuitry? A Randomized Trial of Exercise and Binge Drinking

University of Minho0 sites60 target enrollmentStarted: January 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Behavioral: binge episodes

Study Overview

Brief Summary

The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD.

Detailed Description

The proposed research plan focuses on the identification of changes in the structural and functional brain parameters (e.g. volume, brain activity), in response to a physical exercise (PE) protocol, on the neurocircuitry of addiction, after a 4 month-intervention program in college binge drinkers (BDs). The main objectives of this proposal are: O1) to evaluate the potential benefits of PE on the brain structure and function, particularly in the neurocircuitry of addiction, in a sample of Portuguese college students with a binge drinking pattern of alcohol use; and O2) to determine whether the PE intervention reduces craving and alcohol consumption levels in BDs. The present project will involve: i) a pre-intervention comprehensive evaluation of behavioral (alcohol consumption), psychological (craving levels), physiological (VO2, HRV), and neurological (neuroimaging) variables; ii) a training phase consisting of 48 sessions (3 weekly sessions*16 weeks) of aerobic (exp group 1), agility-cognitive (exp group 2) exercise and stretching (control group; iii) a post-intervention evaluation of behavioral, physiological, and neurological (neuroimaging) variables; iv) and a 6 months' follow- up evaluation of behavioral, physiologicaln and cognitive variables. A randomized controlled trial will be implemented at the University of Minho. It will include a total of 60 college students with a binge drinking pattern of alcohol intake, 20 participants per condition.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 24 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •binge drinking > or = 5 ; > or =4 for women alcoholic drinks
  • •in the same time window (±2h)
  • •at least once per month
  • •<150 minutes of physical activity per week

Exclusion Criteria

  • •Major and/or unstable medical conditions
  • •Physical limitations that may constraint the practice of exercise
  • •Cardiovascular and respiratory insufficiency
  • •History of traumatic brain injury or neurological disorder
  • •Non-corrected sensory deficits
  • •Personal history of psychopathological disorders
  • •Family history of alcoholism or substance abuse in first degree relatives
  • •Consumption of medical drugs with psychoactive effects (e.g., sedatives or anxiolytics) during the month previous to the assessment
  • •Use of illegal drugs and AUDIT scores >20
  • •MRI contraindications
  • •Current or previous (past year) participation in a physical exercise program

Arms & Interventions

Control condition

Active Comparator

Participants allocated to the Control condition will be following a stretching/relaxation training program.

Intervention: Stretching/relaxation (Behavioral)

Experimental condition 1

Experimental

Participants allocated to the Experimental condition 1 will be following a aerobic exercise training program.

Intervention: Aerobic Exercise (Behavioral)

Experimental condition 2

Experimental

Participants allocated to the Experimental condition 2 will be following an agility-cognitive exercise training program.

Intervention: Agility-Cognitive Exercise (Behavioral)

Outcomes

Primary Outcomes

Behavioral: binge episodes

Time Frame: Through study completion, an average of 1 year

Number of binge drinking episodes

Psychological (craving levels)

Time Frame: Through study completion, an average of 1 year

Scores in the Alcohol Craving Questionnaire (The cutoff points for total scale points are: 12-17 = minimal desire, 18-25 = mild, 26-42 = moderate and 43 or more = severe)

Brain structural connectivity - MD

Time Frame: Through study completion, an average of 1 year

Structural connectivity-mean diffusivity-a scalar measure between zero and one that describes the total diffusion within a voxel

Brain structural connectivity - RD

Time Frame: Through study completion, an average of 1 year

Structural connectivity-radial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.

Behavioral : drunkenness

Time Frame: Through study completion, an average of 1 year

Percentage of drunkenness

Brain structure

Time Frame: Through study completion, an average of 1 year

Structure-volume in liters

Brain structural connectivity - AD

Time Frame: Through study completion, an average of 1 year

Structural connectivity-axial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.

Brain function-resting state

Time Frame: Through study completion, an average of 1 year

Functional connectivity for resting-state fMRI

Brain structural connectivity- FA

Time Frame: Through study completion, an average of 1 year

Structural connectivity-fractional anisotropy-scalar value between zero and one within a voxel that describes the degree of anisotropy of a diffusion process

Behavioral: alcohol consumption

Time Frame: Through study completion, an average of 1 year

Number of drinks per binge drinking episode

Brain function

Time Frame: Through study completion, an average of 1 year

Bold signal for Task-related fMRI

Secondary Outcomes

  • Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time(Through study completion, an average of 1 year)
  • Monetary Incentive Delay Task (included in the fMRI paradigm) - hits(Through study completion, an average of 1 year)
  • Brain-derived neurotrophic factor (BDNF)(Through study completion, an average of 1 year)
  • Dopamine(Through study completion, an average of 1 year)
  • Maximal oxygen consumption (VO2max)(Through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sonia Sousa

Principal Investigator

University of Minho

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