Clinical trial NCT03502486: The Effects of an Acute Bout of Exercise on Alcohol and Cocaine Craving - an fNIRS Study
Official title: The Effects of Acute Bouts of Moderate and Intense Exercise on Alcohol and Cocaine Craving - an fNIRS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Psychiatric Hospital of the University of Basel
First posted: 2018-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stroop test accuracy
timeFrame: Change from Baseline after 20 minute acute condition
measure: Self-reported craving
timeFrame: Change from Baseline after 20 minute acute condition
measure: Cerebral oxygenation in prefrontal cortex
timeFrame: Change from Baseline after 20 minute acute condition
measure: Stroop test reaction time
timeFrame: Change from Baseline after 20 minute acute condition
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Sport, Exercise and Health, University of Basel
Study officials:
affiliation: University of Basel
name: Flora Colledge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.