NCT03508362: STNdrugaddict

Neurobiological Substrate of Social Context on Cognitive Control in Drug Users

Status unknown NA Last updated 25 April 2018

What this trial tests

NA trial testing Functional Magnetic Resonance Imaging (fRMI) in Drug Use in 50 participants. Status unknown.

Timeline

16 April 2018

Primary endpoint
15 April 2020

15 April 2020

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	50
Start date	16 April 2018
Primary completion	15 April 2020
Estimated completion	15 April 2020
Sites	1 location across France

Drugs / interventions tested

• Functional Magnetic Resonance Imaging (fRMI)

Conditions studied

• Drug Use — all drugs for Drug Use →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 18 to 65, any sex, with Drug Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.