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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minho

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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