Physical ExerciseREWIREDNCT06317753
Can Exercise Rewire the Brain Addiction Circuitry?
A study testing Aerobic Exercise, Agility-Cognitive Exercise and Stretching/relaxation in people with Physical Exercise, run by University of Minho.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exercise
- What is being tested?
- Aerobic Exercise, Agility-Cognitive Exercise and Stretching/relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Adriana Sampaio, PhD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Exercise
- Being tested
- Aerobic Exercise, Agility-Cognitive Exercise, Stretching/relaxation
- Keywords
- Addiction circuitry, Binge drinking, Neuroimaging
- Medical subject headings
- Motor Activity, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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
Agility-Cognitive ExerciseBehavioural
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
Stretching/relaxationBehavioural
Participants allocated to the stretching control condition will be following a 4 month-intervention protocol of 1 weekly session with a 50 minutes duration
| Study group | Role | What they receive |
|---|---|---|
| Experimental condition 1 | Experimental | Participants allocated to the Experimental condition 1 will be following a aerobic exercise training program. Receives: Behavioral: Aerobic Exercise |
| Experimental condition 2 | Experimental | Participants allocated to the Experimental condition 2 will be following an agility-cognitive exercise training program. Receives: Behavioral: Agility-Cognitive Exercise |
| Control condition | Active comparator | Participants allocated to the Control condition will be following a stretching/relaxation training program. Receives: Behavioral: Stretching/relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral: alcohol consumption
Number of drinks per binge drinking episode
Measured: Through study completion, an average of 1 year
Behavioral: binge episodes
Number of binge drinking episodes
Measured: Through study completion, an average of 1 year
Behavioral : drunkenness
Percentage of drunkenness
Measured: Through study completion, an average of 1 year
Psychological (craving levels)
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)
Measured: Through study completion, an average of 1 year
Brain structure
Structure-volume in liters
Measured: Through study completion, an average of 1 year
Brain structural connectivity- FA
Structural connectivity-fractional anisotropy-scalar value between zero and one within a voxel that describes the degree of anisotropy of a diffusion process
Measured: Through study completion, an average of 1 year
Brain structural connectivity - MD
Structural connectivity-mean diffusivity-a scalar measure between zero and one that describes the total diffusion within a voxel
Measured: Through study completion, an average of 1 year
Brain structural connectivity - AD
Structural connectivity-axial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.
Measured: Through study completion, an average of 1 year
Brain structural connectivity - RD
Structural connectivity-radial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.
Measured: Through study completion, an average of 1 year
Brain function
Bold signal for Task-related fMRI
Measured: Through study completion, an average of 1 year
Brain function-resting state
Functional connectivity for resting-state fMRI
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Monetary Incentive Delay Task (included in the fMRI paradigm) - hits
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.
Measured: Through study completion, an average of 1 year
Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time
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.
Measured: Through study completion, an average of 1 year
Maximal oxygen consumption (VO2max)
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.
Measured: Through study completion, an average of 1 year
Brain-derived neurotrophic factor (BDNF)
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.
Measured: Through study completion, an average of 1 year
Dopamine
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Sousa, University of Minho
- Investigators
- Sónia Sousa, PhD, Principal investigator, Research Center in Psychology, School of Psychology, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317753
- Sponsor's protocol ID
- UMinho1
- Acronym
- REWIRED
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Exercise Rewire the Brain Addiction Circuitry? A Randomized Trial of Exercise and Binge Drinking
- ClinicalTrials.gov ID
- NCT06317753
- Acronym / sponsor ID
- REWIRED / UMinho1
- Conditions
- Physical Exercise
- Keywords
- Addiction circuitry, Binge drinking, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental condition 1 | Experimental | Behavioral: Aerobic ExerciseParticipants allocated to the Experimental condition 1 will be following a aerobic exercise training program. |
| Experimental condition 2 | Experimental | Behavioral: Agility-Cognitive ExerciseParticipants allocated to the Experimental condition 2 will be following an agility-cognitive exercise training program. |
| Control condition | Active comparator | Behavioral: Stretching/relaxationParticipants allocated to the Control condition will be following a stretching/relaxation training program. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseParticipants 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 | Behavioural | Experimental condition 1 |
| Agility-Cognitive ExerciseParticipants 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 | Behavioural | Experimental condition 2 |
| Stretching/relaxationParticipants allocated to the stretching control condition will be following a 4 month-intervention protocol of 1 weekly session with a 50 minutes duration | Behavioural | Control condition |
Primary outcome
Behavioral: alcohol consumption
Time frame: Through study completion, an average of 1 year
Number of drinks per binge drinking episode
Behavioral: binge episodes
Time frame: Through study completion, an average of 1 year
Number of binge drinking episodes
Behavioral : drunkenness
Time frame: Through study completion, an average of 1 year
Percentage of drunkenness
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 structure
Time frame: Through study completion, an average of 1 year
Structure-volume in liters
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
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 - 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 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.
Brain function
Time frame: Through study completion, an average of 1 year
Bold signal for Task-related fMRI
Brain function-resting state
Time frame: Through study completion, an average of 1 year
Functional connectivity for resting-state fMRI
5 secondary outcomes
Monetary Incentive Delay Task (included in the fMRI paradigm) - hits
Time frame: 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
Maximal oxygen consumption (VO2max)
Time frame: Through study completion, an average of 1 year
Brain-derived neurotrophic factor (BDNF)
Time frame: Through study completion, an average of 1 year
Dopamine
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriana Sampaio, PhD contact
Sónia Sousa, PhD principal investigator
Research Center in Psychology, School of Psychology, University of Minho
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Agility-Cognitive Exercise and Stretching/relaxation in people with Physical Exercise, run by University of Minho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sónia Sousa, PhD (+351917824280, soniamachado@psi.uminho.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral: alcohol consumption (time frame: Through study completion, an average of 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.