Can Exercise Rewire the Brain Addiction Circuitry?

Physical Exercise Clinical Trial

— REWIRED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317753
• Other study ID #: UMinho1
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: University of Minho
• Contact: Sónia Sousa, PhD
• Phone: +351917824280
• Email: soniamachado[@]psi.uminho.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Binge Drinking
• Physical Exercise

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral: alcohol consumption	Number of drinks per binge drinking episode	Through study completion, an average of 1 year
Primary	Behavioral: binge episodes	Number of binge drinking episodes	Through study completion, an average of 1 year
Primary	Behavioral : drunkenness	Percentage of drunkenness	Through study completion, an average of 1 year
Primary	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
Primary	Brain structure	Structure-volume in liters	Through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Brain function	Bold signal for Task-related fMRI	Through study completion, an average of 1 year
Primary	Brain function-resting state	Functional connectivity for resting-state fMRI	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year