Clinical trial NCT06317753: Can Exercise Rewire the Brain Addiction Circuitry?
Official title: Can Exercise Rewire the Brain Addiction Circuitry? A Randomized Trial of Exercise and Binge Drinking
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Exercise
Keywords: Addiction circuitry
Binge drinking
Neuroimaging
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Behavioral: alcohol consumption
timeFrame: Through study completion, an average of 1 year
measure: Behavioral: binge episodes
timeFrame: Through study completion, an average of 1 year
measure: Behavioral : drunkenness
timeFrame: Through study completion, an average of 1 year
measure: Psychological (craving levels)
timeFrame: Through study completion, an average of 1 year
measure: Brain structure
timeFrame: Through study completion, an average of 1 year
measure: Brain structural connectivity- FA
timeFrame: Through study completion, an average of 1 year
measure: Brain structural connectivity - MD
timeFrame: Through study completion, an average of 1 year
measure: Brain structural connectivity - AD
timeFrame: Through study completion, an average of 1 year
measure: Brain structural connectivity - RD
timeFrame: Through study completion, an average of 1 year
measure: Brain function
timeFrame: Through study completion, an average of 1 year
measure: Brain function-resting state
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Monetary Incentive Delay Task (included in the fMRI paradigm) - hits
timeFrame: Through study completion, an average of 1 year
measure: Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time
timeFrame: Through study completion, an average of 1 year
measure: Maximal oxygen consumption (VO2max)
timeFrame: Through study completion, an average of 1 year
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: Through study completion, an average of 1 year
measure: Dopamine
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Research Center in Psychology, School of Psychology, University of Minho
name: Sónia Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
References: