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NCT Number: NCT06317753

Can Exercise Rewire the Brain Addiction Circuitry?

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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

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

Agility-Cognitive Exercise

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

Stretching/relaxation

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

Primary outcomes

  1. Behavioral: alcohol consumption

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

    Number of drinks per binge drinking episode

  2. Behavioral: binge episodes

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

    Number of binge drinking episodes

  3. Behavioral : drunkenness

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

    Percentage of drunkenness

  4. 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)

  5. Brain structure

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

    Structure-volume in liters

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. Brain function

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

    Bold signal for Task-related fMRI

  11. Brain function-resting state

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

    Functional connectivity for resting-state fMRI

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana Sampaio, PhD

CONTACT

[email protected]

Sónia Sousa, PhD

CONTACT

[email protected]

+351917824280

Sponsors and collaborators

Lead sponsor

University of Minho

Other

Registry information

Official study title

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

Acronym: REWIRED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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