Neurobiological Substrate of Social Context on Cognitive Control in Drug Users
STNdrugaddict
2 other identifiers
interventional
50
1 country
1
Brief Summary
The aim of the present project is to reveal, using Functional Magnetic Resonance Imaging (fMRI) in drug users, a specific modulation of brain structures and circuits involved in cognitive control (and especially those of inhibitory control) and reward while subjects are performing under the influence of drug-associated cues and in various social contexts. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2018
CompletedStudy Start
First participant enrolled
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2020
CompletedApril 25, 2018
April 1, 2018
2 years
April 16, 2018
April 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Functional MRI highlighting a specific modulation of the structures involved in the cognitive control circuit
Compare in each group the regional brain activity through the measurement of cerebral oxygenation (blood oxygenation level dependent, BOLD). Increased activity in the subthalamic nucleus (STN) in relation to drug use.
24 months
Study Arms (2)
Drug user
EXPERIMENTALRegular use of cocaine
Healthy volunteers
ACTIVE COMPARATORnon-drug user
Interventions
Acquisition of a functional MRI on the sub thalamic nucleus
Eligibility Criteria
You may qualify if:
- Drug Users Group
- 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
You may not qualify if:
- protected persons
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-Olivier ARNAUD, Director
Assistance Publique Hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2018
First Posted
April 25, 2018
Study Start
April 16, 2018
Primary Completion
April 15, 2020
Study Completion
April 15, 2020
Last Updated
April 25, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share