Menu
Not yet recruiting NCT06317753

Can Exercise Rewire the Brain Addiction Circuitry?

No phase Interventional Physical Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic Exercise, Agility-Cognitive Exercise, Stretching/relaxation.
Who it may be relevant to
Registry conditions: Physical Exercise. Basic parameters: 18 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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
  • 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
  • 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

Primary outcome measures

  • Behavioral: alcohol consumption [Time frame: Through study completion, an average of 1 year]
  • Behavioral: binge episodes [Time frame: Through study completion, an average of 1 year]
  • Behavioral : drunkenness [Time frame: Through study completion, an average of 1 year]
  • Psychological (craving levels) [Time frame: Through study completion, an average of 1 year]
  • Brain structure [Time frame: Through study completion, an average of 1 year]
  • Brain structural connectivity- FA [Time frame: Through study completion, an average of 1 year]
  • Brain structural connectivity - MD [Time frame: Through study completion, an average of 1 year]
  • Brain structural connectivity - AD [Time frame: Through study completion, an average of 1 year]
  • Brain structural connectivity - RD [Time frame: Through study completion, an average of 1 year]
  • Brain function [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06317753 · UMinho1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗