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

April 19, 2018 updated by: Flora Colledge, University of Basel

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Basel, Switzerland, 4052
        • Recruiting
        • Department of Sport, Exercise and Health, University of Basel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroop test accuracy
Time Frame: Change from Baseline after 20 minute acute condition
Accuracy on Stroop test
Change from Baseline after 20 minute acute condition
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)
Change from Baseline after 20 minute acute condition
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
Change from Baseline after 20 minute acute condition
Stroop test reaction time
Time Frame: Change from Baseline after 20 minute acute condition
Reaction time on Stroop test
Change from Baseline after 20 minute acute condition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Collaborators

Psychiatric Hospital of the University of Basel

Investigators

  • Principal Investigator: Flora Colledge, PhD, University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2017

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBasel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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