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

Primary Purpose

Substance Use Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Moderate exercise
Intense exercise
Reading
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Sport, Exercise and Health, University of BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Moderate exercise

Intense Exercise

Rest

Arm Description

20 minutes of cycle ergometry at 50 - 60% of heart rate max.

20 minutes of cycle ergometry at 70 - 80% of heart rate max.

20 minutes of seated reading.

Outcomes

Primary Outcome Measures

Stroop test accuracy
Accuracy on Stroop test
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)
Cerebral oxygenation in prefrontal cortex
Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex
Stroop test reaction time
Reaction time on Stroop test

Secondary Outcome Measures

Full Information

First Posted
April 5, 2018
Last Updated
April 19, 2018
Sponsor
University of Basel
Collaborators
Psychiatric Hospital of the University of Basel
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1. Study Identification

Unique Protocol Identification Number
NCT03502486
Brief Title
The Effects of an Acute Bout of Exercise on Alcohol and Cocaine Craving - an fNIRS Study
Acronym
ExAlCo
Official Title
The Effects of Acute Bouts of Moderate and Intense Exercise on Alcohol and Cocaine Craving - an fNIRS Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel
Collaborators
Psychiatric Hospital of the University of Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate exercise
Arm Type
Experimental
Arm Description
20 minutes of cycle ergometry at 50 - 60% of heart rate max.
Arm Title
Intense Exercise
Arm Type
Experimental
Arm Description
20 minutes of cycle ergometry at 70 - 80% of heart rate max.
Arm Title
Rest
Arm Type
Active Comparator
Arm Description
20 minutes of seated reading.
Intervention Type
Other
Intervention Name(s)
Moderate exercise
Intervention Description
20 minutes of cycle ergometry at 50-60% of heart rate max
Intervention Type
Other
Intervention Name(s)
Intense exercise
Intervention Description
20 minutes of cycle ergometry at 70-80% of heart rate max
Intervention Type
Other
Intervention Name(s)
Reading
Intervention Description
20 minutes of seated reading
Primary Outcome Measure Information:
Title
Stroop test accuracy
Description
Accuracy on Stroop test
Time Frame
Change from Baseline after 20 minute acute condition
Title
Self-reported craving
Description
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)
Time Frame
Change from Baseline after 20 minute acute condition
Title
Cerebral oxygenation in prefrontal cortex
Description
Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex
Time Frame
Change from Baseline after 20 minute acute condition
Title
Stroop test reaction time
Description
Reaction time on Stroop test
Time Frame
Change from Baseline after 20 minute acute condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flora Colledge, PhD
Phone
0041622074787
Email
flora.colledge@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flora Colledge, PhD
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Sport, Exercise and Health, University of Basel
City
Basel
ZIP/Postal Code
4052
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora Colledge, PhD
Phone
0041612074787
Email
flora.colledge@unibas.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30594237
Citation
Colledge F, Ludyga S, Mucke M, Puhse U, Gerber M. The effects of an acute bout of exercise on neural activity in alcohol and cocaine craving: study protocol for a randomised controlled trial. Trials. 2018 Dec 29;19(1):713. doi: 10.1186/s13063-018-3062-0.
Results Reference
derived

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

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