Can Exercise Rewire the Brain Addiction Circuitry?

NCT ID: NCT06317753

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Exercise

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The protocol includes a randomized controlled trial with a follow-up at three months involving three groups of adolescents (18-24 Y) -experimental group 1, will be enrolled in the Aerobic program, experimental group 2 will be involved in the agility program, and an active control group that will be participating in a stretching program. Participants will be randomly assigned to each group.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental condition 1

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

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

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 condition 2

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

Group Type EXPERIMENTAL

Agility-Cognitive Exercise

Intervention Type BEHAVIORAL

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

Control condition

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

Group Type ACTIVE_COMPARATOR

Stretching/relaxation

Intervention Type BEHAVIORAL

Participants allocated to the stretching control condition will be following a 4 month-intervention protocol of 1 weekly session with a 50 minutes duration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minho

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sonia Sousa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sónia Sousa, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Center in Psychology, School of Psychology, University of Minho

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sónia Sousa, PhD

Role: CONTACT

+351917824280

Adriana Sampaio, PhD

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UMinho1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acute Cognition and Exercise
NCT05078203 COMPLETED NA