Substance Use DisordersExAlCoNCT03502486
The Effects of an Acute Bout of Exercise on Alcohol and Cocaine Craving - an fNIRS Study
A study testing Moderate exercise, Intense exercise and Reading in people with Substance Use Disorders, run by University of Basel at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Moderate exercise, Intense exercise and Reading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jul 2017to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- Pregnancy
- Questionable findings during resting ECG screen
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Sport, Exercise and Health, University of Basel
Basel, 4052
Flora Colledge, PhD, 0041612074787, flora.colledge@unibas.ch
About this study
Official title: 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
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Moderate exercise, Intense exercise, Reading
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate exerciseOther
20 minutes of cycle ergometry at 50-60% of heart rate max
Intense exerciseOther
20 minutes of cycle ergometry at 70-80% of heart rate max
ReadingOther
20 minutes of seated reading
| Study group | Role | What they receive |
|---|---|---|
| Moderate exercise | Experimental | 20 minutes of cycle ergometry at 50 - 60% of heart rate max. Receives: Other: Moderate exercise |
| Intense Exercise | Experimental | 20 minutes of cycle ergometry at 70 - 80% of heart rate max. Receives: Other: Intense exercise |
| Rest | Active comparator | 20 minutes of seated reading. Receives: Other: Reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop test accuracy
Accuracy on Stroop test
Measured: Change from Baseline after 20 minute acute condition
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)
Measured: Change from Baseline after 20 minute acute condition
Cerebral oxygenation in prefrontal cortex
Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex
Measured: Change from Baseline after 20 minute acute condition
Stroop test reaction time
Reaction time on Stroop test
Measured: Change from Baseline after 20 minute acute condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start5 Jul 2017
- Primary completionAug 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel
- Responsible party
- Principal investigator, Flora Colledge, University of Basel
- Investigators
- Flora Colledge, PhD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502486
- Sponsor's protocol ID
- UBasel
- Acronym
- ExAlCo
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30594237
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Bouts of Moderate and Intense Exercise on Alcohol and Cocaine Craving - an fNIRS Study
- ClinicalTrials.gov ID
- NCT03502486
- Acronym / sponsor ID
- ExAlCo / UBasel
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate exercise | Experimental | Other: Moderate exercise20 minutes of cycle ergometry at 50 - 60% of heart rate max. |
| Intense Exercise | Experimental | Other: Intense exercise20 minutes of cycle ergometry at 70 - 80% of heart rate max. |
| Rest | Active comparator | Other: Reading20 minutes of seated reading. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (2 listed)
- Pregnancy
- Questionable findings during resting ECG screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate exercise20 minutes of cycle ergometry at 50-60% of heart rate max | Other | Moderate exercise |
| Intense exercise20 minutes of cycle ergometry at 70-80% of heart rate max | Other | Intense Exercise |
| Reading20 minutes of seated reading | Other | Rest |
Primary outcome
Stroop test accuracy
Time frame: Change from Baseline after 20 minute acute condition
Accuracy on Stroop test
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)
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
Stroop test reaction time
Time frame: Change from Baseline after 20 minute acute condition
Reaction time on Stroop test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 30594237Colledge 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.
- Individual participant dataSharing planned: No
Related trials for Substance Use Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flora Colledge, PhD principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate exercise, Intense exercise and Reading in people with Substance Use Disorders, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flora Colledge, PhD (0041622074787, flora.colledge@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop test accuracy (time frame: Change from Baseline after 20 minute acute condition). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.