The Effects of an Acute Bout of Exercise on Alcohol and Cocaine Craving - an fNIRS Study

Study Overview
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Brief Summary
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The study is a crossover randomised controlled trial. Alcohol or cocaine dependent participants will be recruited from inpatient and outpatient psychiatric treatment centres, on the approval of their treating physician. A healthy control group will be recruited using online advertising. All participants will undergo each of three conditions in a randomised order; 1) 20 minutes of cycle ergometry at 50-60% of maximum heart rate; 2) 20 minutes of exercise at 70-80% of maximum heart rate; 3) 20 minutes of quiet reading. Immediately before and after each condition, participants will be asked to complete a computerised Stroop test, watch a film containing substance-related images, and self-report craving levels. During the Stroop test and film viewing, participants' neural activity will be measured via functional near-infrared spectroscopy

Detailed Description
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The aim of this study is to examine whether, following acute exercise bouts at moderate and high intensities, reduced craving and increased inhibitory control can be observed in alcohol or cocaine dependent individuals. As the focus of this study is the potential of exercise to be integrated into treatment, individuals in treatment for their dependence, who have been abstinent for a short period, will be recruited.

Official Title
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The Effects of Acute Bouts of Moderate and Intense Exercise on Alcohol and Cocaine Craving - an fNIRS Study

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Other: Moderate exercise
* Other: Intense exercise
* Other: Reading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For alcohol or cocaine dependent participants: meeting three or more of the DSM-IV criteria for substance dependence (as determined by treating physician); minimum of 20 days and maximum of 40 days abstinence from substance of dependence; able to understand and complete the informed consent; able to travel to study site independently, as confirmed by the treating psychiatrist; assessed for physical and mental fitness by treating physician and cleared to take part in the study; fewer than 3 hours of physical exercise or sport per week; For healthy controls: fewer than 3 hours of physical exercise or sport per week; no history of problematic alcohol or illicit drug consumption. Exclusion Criteria: Pregnancy Questionable findings during resting ECG screen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate exercise<br>20 minutes of cycle ergometry at 50 - 60% of heart rate max. | Other: Moderate exercise<br>* 20 minutes of cycle ergometry at 50-60% of heart rate max<br>|
| Experimental: Intense Exercise<br>20 minutes of cycle ergometry at 70 - 80% of heart rate max. | Other: Intense exercise<br>* 20 minutes of cycle ergometry at 70-80% of heart rate max<br>|
| Active Comparator: Rest<br>20 minutes of seated reading. | Other: Reading<br>* 20 minutes of seated reading<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroop test accuracy | Accuracy on Stroop test | Change from Baseline after 20 minute acute condition | 
| Self-reported craving | Sum score on Alcohol Craving Questionnaire Short Form (scale range 12 to 84, higher scores representing greater craving) or Cocaine Craving Questionnaire - Brief (scale range 10 to 70, higher scores representing greater craving) | Change from Baseline after 20 minute acute condition | 
| Cerebral oxygenation in prefrontal cortex | Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex | Change from Baseline after 20 minute acute condition | 
| Stroop test reaction time | Reaction time on Stroop test | Change from Baseline after 20 minute acute condition |