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

Substance Use Disorders Clinical Trial

— ExAlCo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03502486
• Other study ID #: UBasel
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2018
• Last updated: April 19, 2018
• Start date: July 5, 2017
• Est. completion date: November 2020

Study information

• Verified date: April 2018
• Source: University of Basel
• Contact: Flora Colledge, PhD
• Phone: 0041622074787
• Email: flora.colledge[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Moderate exercise
20 minutes of cycle ergometry at 50-60% of heart rate max
• Intense exercise
20 minutes of cycle ergometry at 70-80% of heart rate max
• Reading
20 minutes of seated reading

Locations

Country	Name	City	State
Switzerland	Department of Sport, Exercise and Health, University of Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University of Basel	Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroop test accuracy	Accuracy on Stroop test	Change from Baseline after 20 minute acute condition
Primary	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
Primary	Cerebral oxygenation in prefrontal cortex	Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex	Change from Baseline after 20 minute acute condition
Primary	Stroop test reaction time	Reaction time on Stroop test	Change from Baseline after 20 minute acute condition