Can Exercise Rewire the Brain Addiction Circuitry?

NCT06317753 | Not Yet Recruiting

• 1 other identifier: UMinho1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Physical Exercise

Keywords

Addiction circuitry; Binge drinking; Neuroimaging

Outcome Measures

Primary Outcomes (11)

• Behavioral: alcohol consumption

  Number of drinks per binge drinking episode

  Through study completion, an average of 1 year

• Behavioral: binge episodes

  Number of binge drinking episodes

  Through study completion, an average of 1 year

• Behavioral : drunkenness

  Percentage of drunkenness

  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)

  Through study completion, an average of 1 year

• Brain structure

  Structure-volume in liters

  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

  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

  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.

  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.

  Through study completion, an average of 1 year

• Brain function

  Bold signal for Task-related fMRI

  Through study completion, an average of 1 year

• Brain function-resting state

  Functional connectivity for resting-state fMRI

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Monetary Incentive Delay Task (included in the fMRI paradigm) - hits

  Through study completion, an average of 1 year

• Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time

  Through study completion, an average of 1 year

• Maximal oxygen consumption (VO2max)

  Through study completion, an average of 1 year

• Brain-derived neurotrophic factor (BDNF)

  Through study completion, an average of 1 year

• Dopamine

  Through study completion, an average of 1 year

Study Arms (3)

Experimental condition 1

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Experimental condition 2

EXPERIMENTAL

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

Behavioral: Agility-Cognitive Exercise

Control condition

ACTIVE COMPARATOR

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

Behavioral: Stretching/relaxation

Interventions

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

Experimental condition 1

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

Experimental condition 2

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

Control condition

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: 50% male, 50% female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minho: lead

MeSH Terms

Conditions

Motor Activity; Binge Drinking

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sónia Sousa, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sónia Sousa, PhD

CONTACT

+351917824280; soniamachado@psi.uminho.pt

Adriana Sampaio, PhD

CONTACT

adriana.sampaio@psi.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 19, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03