Can Exercise Rewire the Brain Addiction Circuitry? (REWIRED)

March 31, 2025 updated by: Sonia Sousa, University of Minho

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental condition 1
Participants allocated to the Experimental condition 1 will be following a aerobic exercise training program.
Behavioral: Aerobic Exercise
Participants allocated to the Aerobic condition will be following a 4 month-intervention aerobic exercise protocol of 3 weekly interleaved sessions with a 50 minutes duration
Experimental: Experimental condition 2
Participants allocated to the Experimental condition 2 will be following an agility-cognitive exercise training program.
Behavioral: Agility-Cognitive Exercise
Participants allocated to the Agility-Cognitive condition will be following a 4 month-intervention agility-cognitive exercise protocol of 3 weekly interleaved sessions with a 50 minutes duration
Active Comparator: Control condition
Participants allocated to the Control condition will be following a stretching/relaxation training program.
Behavioral: Stretching/relaxation
Participants allocated to the stretching control condition will be following a 4 month-intervention protocol of 1 weekly session with a 50 minutes duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral: alcohol consumption
Time Frame: Through study completion, an average of 1 year
Number of drinks per binge drinking episode
Through study completion, an average of 1 year
Behavioral: binge episodes
Time Frame: Through study completion, an average of 1 year
Number of binge drinking episodes
Through study completion, an average of 1 year
Behavioral : drunkenness
Time Frame: Through study completion, an average of 1 year
Percentage of drunkenness
Through study completion, an average of 1 year
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)
Through study completion, an average of 1 year
Brain structure
Time Frame: Through study completion, an average of 1 year
Structure-volume in liters
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Brain function
Time Frame: Through study completion, an average of 1 year
Bold signal for Task-related fMRI
Through study completion, an average of 1 year
Brain function-resting state
Time Frame: Through study completion, an average of 1 year
Functional connectivity for resting-state fMRI
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monetary Incentive Delay Task (included in the fMRI paradigm) - hits
Time Frame: Through study completion, an average of 1 year
Accuracy, measured through the number of hits to assess the hypothetical differences in participant's level of achievement between the pretest, posttest and follow-up assessments.
Through study completion, an average of 1 year
Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time
Time Frame: Through study completion, an average of 1 year
Reaction times, measured as seconds needed to give a response to assess the hypothetical differences in participant's level of achievement between the pretest, posttest and follow-up assessments.
Through study completion, an average of 1 year
Maximal oxygen consumption (VO2max)
Time Frame: Through study completion, an average of 1 year
VO2max (ml/kg/min) will be measured in the pretest and posttest evaluations to assess the effects of the physical exercise protocol on cardiovascular fitness.
Through study completion, an average of 1 year
Brain-derived neurotrophic factor (BDNF)
Time Frame: Through study completion, an average of 1 year
BDNF (pg/ml) concentrations measured in saliva will be measured in pre-intervention, post-intervention, at the midpoint of the intervention (2 months), and at the follow-up to assess the effects of the physical exercise protocol on neuroplasticity-related molecular markers.
Through study completion, an average of 1 year
Dopamine
Time Frame: Through study completion, an average of 1 year
Dopamine (pg/ml) concentrations measured in urine will be measured in pre-intervention, post-intervention, at the midpoint of the intervention (2 months), and at the follow-up to assess the effects of the physical exercise protocol on reward-related molecular markers.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Investigators

  • Principal Investigator: Sónia Sousa, PhD, Research Center in Psychology, School of Psychology, University of Minho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 2, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMinho1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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