Neurobiological Substrate of Social Context on Cognitive Control in Drug Users
NCT ID: NCT03508362
Last Updated: 2018-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-04-16
2020-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This hypothesis, based on the animal work, is that the subthalamic nucleus (STN) should play a critical role in these processes. Addictive behaviour can be seen as a loss of control resulting from reduced inhibitory control, leading to compulsive drug use. These disorders are known to be associated with a hypoactivation of specific frontal regions such as the anterior cingulate cortex or the prefrontal cortex.
For the present experiment, it is chosen to use a procedure well established for neurophysiological and behavioural assessment of inhibitory processes : the " stop-signal reaction time task ".
This task requires to inhibit a motor response (press a button) at the onset of a stop signal (a tone) that occurs while the response is already engaged. In this task associated with fMRI, it was previously shown that the STN is involved in the control of inhibition. These results confirm our data in the rat, and especially those showing that STN lesions block the ability to stop. The stop signal task will thus be appropriate to study the effect of the social context on inhibitory processes in a population of cocaine users.
In cocaine abusers, it was shown that inhibitory processes are affected. Here we aim at testing this population of subjects while they perform the stop task, but adding an implicit cognitive load induced by visual cues associated or not with cocaine intake. Since it want to assess the influence of a peer on both the performance and the associated cerebral activities, it will also control the presence of a peer observer in the procedure.
There will thus be three experimental factors, one inter-subject factor (the experimental group, cocaine users or controls) and two intra-subject factors (cocaine associated or neutral cue; presence of a peer observer). The "stop-signal" task should induce increased activity of the STN that should be modulated by the cocaine-associated cues and by the presence of a peer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cognitive Task Development and Implementation for Functional MRI Studies
NCT01036685
Neurobehavioral Signatures of Sign- and Goal-Tracking in Emerging Adults: Translation of a Preclinical Model
NCT07094061
Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally
NCT01365988
Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
NCT01993108
Drugs Brain and Behavior (DDP)
NCT04642820
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drug user
Regular use of cocaine
Functional Magnetic Resonance Imaging (fRMI)
Acquisition of a functional MRI on the sub thalamic nucleus
Healthy volunteers
non-drug user
Functional Magnetic Resonance Imaging (fRMI)
Acquisition of a functional MRI on the sub thalamic nucleus
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Functional Magnetic Resonance Imaging (fRMI)
Acquisition of a functional MRI on the sub thalamic nucleus
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age between 18 and 65 years
* regular use of cocaine and crack
* willing to participate
* able to give consent
* right-handed
Healthy volunteers group
* age between 18 and 65 years
* non-drug user
* willing to participate
* able to give consent
* right-handed
Exclusion Criteria
* lactating women
* intolerance to noise
* not a beneficiary of a social security scheme.
* no signature on the consent form
* significant psychiatric or neurological disorder
* known visual impairment and abnormal vision despite correction
* Contraindication to MRI examination
* Claustrophobia.
* Pregnant women
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Olivier ARNAUD, Director
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-A03395-48
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-64
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.