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Neurobiological Substrate of Social Context on Cognitive Control in Drug Users (STNdrugaddict)

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ClinicalTrials.gov Identifier: NCT03508362
Recruitment Status : Unknown
Verified April 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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.


Condition or disease Intervention/treatment Phase
Drug Use Device: Functional Magnetic Resonance Imaging (fRMI) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neurobiological Substrate of Social Context on Cognitive Control in Drug Users
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug user
Regular use of cocaine
 Device: Functional Magnetic Resonance Imaging (fRMI)
Acquisition of a functional MRI on the sub thalamic nucleus
Active Comparator: Healthy volunteers
non-drug user
 Device: Functional Magnetic Resonance Imaging (fRMI)
Acquisition of a functional MRI on the sub thalamic nucleus


Outcome Measures
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Primary Outcome Measures :
  1. Functional MRI highlighting a specific modulation of the structures involved in the cognitive control circuit [ Time Frame: 24 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Drug Users Group

  • age between 18 and 65 years
  • regular use of cocaine and crack
  • willing to participate
  • able to give consent
  • not meeting any non-inclusion criteria
  • right-handed

Healthy volunteers group

  • age between 18 and 65 years
  • non-drug user
  • willing to participate
  • able to give consent
  • not meeting any non-inclusion criteria
  • right-handed

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508362


Contacts
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Contact: Nicolas SIMON, PU-PH 491744051 ext +33 nicolas.simon@ap-hm.fr
Contact: Christelle Baunez, PhD, HDR 491324062 ext +33 christelle.baunez@univ-amu.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Nicolas SIMON, PU-PH    491744051 ext +33    nicolas.simon@ap-hm.fr   
Contact: Christelle BAUNEZ, PhD, HDR    491324062 ext +33    christelle.baunez@univ-amu.fr   
Principal Investigator: Nicolas SIMON, PU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03508362    
Other Study ID Numbers: 2017-64
2017-A03395-48 ( Registry Identifier: ID RCB )
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No