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

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ClinicalTrials.gov Identifier: NCT03502486
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Psychiatric Hospital of the University of Basel
Information provided by (Responsible Party):
Flora Colledge, University of Basel

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Substance Use Disorders Other: Moderate exercise Other: Intense exercise Other: Reading Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Acute Bouts of Moderate and Intense Exercise on Alcohol and Cocaine Craving - an fNIRS Study
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate exercise
20 minutes of cycle ergometry at 50 - 60% of heart rate max.
Other: Moderate exercise
20 minutes of cycle ergometry at 50-60% of heart rate max

Experimental: Intense Exercise
20 minutes of cycle ergometry at 70 - 80% of heart rate max.
Other: Intense exercise
20 minutes of cycle ergometry at 70-80% of heart rate max

Active Comparator: Rest
20 minutes of seated reading.
Other: Reading
20 minutes of seated reading




Primary Outcome Measures :
  1. Stroop test accuracy [ Time Frame: Change from Baseline after 20 minute acute condition ]
    Accuracy on Stroop test

  2. Self-reported craving [ Time Frame: Change from Baseline after 20 minute acute condition ]
    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)

  3. Cerebral oxygenation in prefrontal cortex [ Time Frame: Change from Baseline after 20 minute acute condition ]
    Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex

  4. Stroop test reaction time [ Time Frame: Change from Baseline after 20 minute acute condition ]
    Reaction time on Stroop test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502486


Contacts
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Contact: Flora Colledge, PhD 0041622074787 flora.colledge@unibas.ch

Locations
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Switzerland
Department of Sport, Exercise and Health, University of Basel Recruiting
Basel, Switzerland, 4052
Contact: Flora Colledge, PhD    0041612074787    flora.colledge@unibas.ch   
Sponsors and Collaborators
University of Basel
Psychiatric Hospital of the University of Basel
Investigators
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Principal Investigator: Flora Colledge, PhD University of Basel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Flora Colledge, Postdoctoral researcher, University of Basel
ClinicalTrials.gov Identifier: NCT03502486     History of Changes
Other Study ID Numbers: UBasel
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents